Safety of changes in the use of noninvasive ventilation and high flow oxygen therapy on reintubation in a surgical intensive care unit: A retrospective cohort study

Stanislas Abrard; Lorine Jean; Emmanuel Rineau; Pauline Dupré; Maxime Léger; Sigismond Lasocki

doi:10.1371/journal.pone.0249035

. 2021 Mar 22;16(3):e0249035. doi: 10.1371/journal.pone.0249035

Safety of changes in the use of noninvasive ventilation and high flow oxygen therapy on reintubation in a surgical intensive care unit: A retrospective cohort study

Stanislas Abrard ^1,^2,^3,^*,^#, Lorine Jean ^1,^#, Emmanuel Rineau ^1,², Pauline Dupré ¹, Maxime Léger ^1,⁴, Sigismond Lasocki ^1,²

Editor: Yu Ru Kou⁵

PMCID: PMC7984629 PMID: 33750979

Abstract

Reintubation after weaning from mechanical ventilation is relatively common and is associated with poor outcomes. Different methods to decrease the reintubation rate post extubation, including noninvasive ventilation, and more recently high-flow oxygen (HFO) therapy, have been proposed. In this study, we aimed to assess the safety of introducing HFO in the post-extubation care of intensive care unit (ICU) patients. We conducted a single-center cohort study of extubated adult patients hospitalized in a surgical ICU and previously mechanically ventilated for > 1 day. Our study consisted of two phases: Phase 1 (before the introduction of HFO from April 2015 to April 2016) and Phase P2 (after the introduction of HFO from April 2017 to April 2018). The primary endpoint was the reintubation rate within 48 hours of extubation. In total, 290 patients (median age 65 years [50–74]; 190 men [65.5%]) were included in the analysis (181 and 109 in Phases 1 and 2, respectively). The results of the post-extubation use of noninvasive methods (noninvasive ventilation and/or HFO) were not significantly different between the two phases (41 [22.7%] versus 29 [26.6%] patients; p = 0.480), however these methods were implemented earlier in Phase 2 (0 versus 4 hours; p = 0.009) and HFO was used significantly more often than noninvasive ventilation (24 [22.0%] versus 25 [13.8%] patients; p = 0.039). The need for reintubation within 48 hours post extubation was significantly lower in Phase 2 (4 [3.7%] versus 20 [11.0%] patients; p = 0.028) but was not significantly different at 7 days post extubation (10 [9.2%] versus 30 [16.6%] patients; p = 0.082). The earlier implementation of noninvasive methods and the increased use of HFO beginning in Phase 2 were safe and effective based on the reintubation rates within the first 48 hours post extubation and after 7 days.

Introduction

In intensive care units (ICUs), patients weaned from invasive mechanical ventilation are at risk of post-extubation respiratory failure (acute respiratory failure [ARF]) and subsequent mechanical ventilation with tracheal reintubation [1,2]. Approximately 10–15% of patients are reintubated within the first 48 hours following extubation [3], with an associated increase in morbidity, mortality, and length of hospital stay [4]. The causes of respiratory failure after extubation include upper airway obstruction, inadequate cough, atelectasis, encephalopathy, and cardiac dysfunction [2,5–7]. Extubation failure is currently defined as the need for reintubation within 48 hours of extubation [8,9]. Three noninvasive methods are available to prevent and/or treat post-extubation ARF: conventional oxygen therapy, high-flow conditioned oxygen therapy (HFO), and noninvasive ventilation (NIV). NIV is one of the recommended treatments for acute hypercapnic and hypoxemic ARF [10]. NIV administered in the post-extubation period can recruit zones of alveolar collapse [11,12], improve oxygenation [13], and minimize the work of breathing [1,14]. Although the use of NIV as supportive treatment to avoid tracheal reintubation is ineffective in 10–50% of patients with post-extubation ARF, two meta-analyses concluded that the early use of NIV could decrease reintubation rates [15,16]. HFO, a newly developed technology that delivers a high flow of high-concentration oxygen via nasal cannula, is able to generate mild continuous positive airway pressure [17], which reduces the work of breathing and clears out upper airway dead space [18]. Compared with conventional oxygen therapy, HFO therapy after extubation improves oxygenation and patient comfort and prevents post-extubation ARF and reintubation in general populations of critically ill patients [3,19]. Unlike NIV, HFO does not provide the continuous positive airway pressure that supports the patient’s inspiratory efforts. Two prospective randomized controlled studies compared post-extubation NIV with HFO and found no difference in reintubation rates in critically ill medical and surgical patients [20,21]. Analyses of these data, pooled in a meta-analysis, showed no significant difference in clinical outcomes between NIV and HFO [22]. However, there is currently limited data on the supportive use of a combination of HFO and NIV for the treatment of post-extubation ARF. Moreover, the use of noninvasive methods has raised safety concerns [23]. These therapies might increase the risk of poor outcomes due to the apparent improvements of patient comfort and oxygenation leading to delayed reintubation.

In our surgical ICU, the potential benefit of HFO has led to a change in post-extubation practices, with more frequent use of HFO in the post-extubation period. The main objective of this study was to assess the safety of this practice change using the rate of reintubation 48 hours after extubation (compared between the two periods, before and after the introduction of HFO) as the primary endpoint.

Methods

Study design and setting

This retrospective cohort study, ARVENiO (Analyse Rétrospective de l’utilisation de la Ventilation Non-invasive et de l’Oxygénothérapie), was approved by the institutional review board of the French Anesthesiology and Critical Care Society (SFAR; 74 rue Raynouard; 75016 Paris France; Chairperson Pr JE. Bazin) on May 27, 2019 (Ethical Committee N°IRB 00010254-2019‐094) and was registered at the National Commission for Information Technology and Civil Liberties (DRCI-CGDE-FO-005), according to French law [24]. During their hospital stay, patients were advised that their data could be used retrospectively for clinical research purposes. Written informed consent is generally waived for observational retrospective studies; however, patients had the right to refuse the use of their data upon request (none of them did) [24]. Our study is reported according to the Strengthening the Reporting of Observational studies in Epidemiology guidelines for reporting observational studies and was conducted in accordance with the Declaration of Helsinki.

This single-center, historical cohort was conducted in our 12-bed surgical ICU. We used data from two periods: April 2015 to April 2016 (Phase one [P1]) and April 2017 to April 2018 (Phase [P2]). Between the two phases, six HFO devices were obtained and all ICU physicians were trained on the benefits and use of HFO, including three bibliographic sessions (literature review). The ICU nurses were also trained by the manufacturer in the use of the HFO device. No other changes in the respiratory management of patients (particularly no changes to ICU protocols) were implemented. A period of one year was chosen between the two phases because the implementation of practice changes is a long-term process and to allow for the inclusion of hospitalized patients from the same seasons. Patient records were accessed from April to July 2020 at the University Hospital of Angers. We first proceeded with the anonymization of the database before performing the data analysis (S1–S4 Tables).

Participants

All adult patients (age ≥ 18 years) who were hospitalized in the intensive care unit, intubated, mechanically ventilated for a duration > 1 day, and extubated during one of the two study phases were included in our cohort.

Variables

Patient characteristics, including age, body mass index, medical history (chronic obstructive pulmonary disease, arterial hypertension, sleep apnea syndrome, coronary artery disease), type of admission (medical, elective surgery, or emergency surgery), arterial partial pressure of oxygen (PaO₂)/fraction of inspired oxygen (FiO₂) ratio (in mmHg) and reason for mechanical ventilation on admission, shock on admission (if applicable; defined as the use of norepinephrine), and Simplified Acute Physiology Score (SAPS II) score were recorded [25]. The date of the first extubation as well as the PaO₂/FiO₂ ratio immediately before extubation were recorded. Additional information was recorded during the first 7 days following extubation, if applicable, including: use of noninvasive methods, time of implementation, physician indication (“prophylactic” to post-extubation ARF prophylaxis or “supportive” treatment of ARF to prevent reintubation to bridge until the underlying process), duration of use and settings (NIV: inspiratory pressure support, positive end expiratory pressure [PEEP], and FiO₂; HFO: flow rate and FiO₂) were recorded during the first 7 days following extubation.

The primary endpoint was the reintubation rate within the first 48 hours after extubation (excluding reintubation for surgery). Secondary endpoints included safety endpoints, such as the time to reintubation (time between extubation and reintubation), length of ICU stay, 28-day mortality, days without mechanical ventilation after 28 days (a value of 0 was assigned if the patient died) and the reintubation rate at day 7 post extubation.

Statistical analysis

Quantitative data are expressed as medians (interquartile range) and were compared using the Mann–Whitney U test. Qualitative data are described as percentages and were compared using Fisher’s exact test or chi-squared test if more than 1 degree of freedom.

For the primary endpoint, patients were separated into two groups, according to phase (P1 or P2). A multivariable analysis of the occurrence of reintubation within the 48 hours after extubation (excluding reintubation for surgery) was compared using Fisher’s exact test. The use of noninvasive methods described by frequency, indication, and combination of methods, were compared by Fisher’s exact test. The survival analysis of the time to reintubation used a univariate log-rank test. A Kaplan Meier-type graphical representation was used to show the survival curves for each group. The other endpoints (time to reintubation, length of ICU stay, 28-day mortality, and days without mechanical ventilation during the first 28 days) were compared using the Mann–Whitney U test.

For some outcomes (i.e., reintubation rate at 48 hours, reintubation rate at 7 days, and survival analysis of the probability of reintubation censored at 7 days), multivariable analyses were performed. Reintubation rates were analyzed using a logistic regression, while the survival analysis of the probability of reintubation used a multivariable Cox cause-specific regression model. The association between the primary endpoint and risk factors for reintubation were expressed by a cause-specific hazard ratio (HR) considering the competitive risks of censored reintubation due to death, or patients discharged prior to the need for reintubation. For all models, we applied a selection process to choose among candidate predictor variables that had a univariable p-value <0.15.

A p-value <0.05 was considered statistically significant. Analyses were performed using R version 3.6.3 and SPSS Statistics version 24.0 (Armonk, NY: IBM Corp).

Results

Study participants

The patient selection flow chart is presented in Fig 1. Among the 302 patients included in the two cohorts, 290 were ultimately included in the analysis (181 in P1; 109 in P2). The majority were men, and median age of participants was 65 years ([50–74]; Table 1). The median SAPS was 48 ([37–59]; Table 1). The number of patients who were admitted following a recent surgery was 196 (67%). The clinical characteristics of the patients were similar between the two phases, except for a higher proportion of patients with coronary artery disease in P1, and a higher incidence of acute respiratory distress syndrome and shock on admission in P2 (Table 1).

Table 1. Baseline patient characteristics.

Characteristics	All (n = 290)	P1 (n = 181)	P2 (n = 109)	p-value
Male sex	190 (65.5)	121 (66.9)	69 (63.3)	0.610
Age, years	65 [50-74]	65 [51-75]	63 [47-72]	0.218
BMI	26.8 [22.5–30.5]	26.8 [22.3–29.9]	26.8 [22.7–31.0]	0.680
SAPS II	48 [37-59]	48 [37-59]	48 [39-59]	0.836
Medical history
COPD	20 (6.9)	10 (5.5)	10 (9.2)	0.242
OSA	19 (6.6)	12 (6.6)	7 (6.4)	1.000
Arterial Hypertension	130 (44.8)	84 (46.4)	46 (42.2)	0.543
Coronary artery disease	26 (9.0)	22 (12.5)	4 (3.7)	0.018
Type of ICU admission				0.908
Emergent surgery	171 (59.0)	108 (59.7)	63 (57.8)
Elective surgery	25 (8.6)	16 (8.8)	9 (8.3)
Medical:	94 (32.4)	57 (31.5)	37 (33.9)
Non-operative trauma	38 (13.1)	19 (10.5)	19 (17.4)
Brain injury	25 (8.6)	19 (10.5)	6 (5.5)
Respiratory failure	14 (4.8)	9 (5.0)	5 (4.6)
Shock/Heart failure	10 (3.4)	9 (5.0)	1 (0.9)
Other	7 (2.4)	1 (0.6)	6 (5.5)
Reason for ICU admission
Pneumonia	34 (11.7)	19 (10.5)	15 (13.8)	0.453
Acute pulmonary edema	3 (1.0)	3 (1.7)	0	0.294
ARDS	13 (4.5)	4 (2.2)	9 (8.3)	0.020
Coma	96 (33.1)	60 (33.1)	36 (33.0)	1.000
Shock	95 (32.8)	43 (23.8)	52 (47.7)	< 0.001
P/F at admission	288 [169-399]	293 [172-418]	277 [167-366]	0.248
Extubation day	2 [1-8]	3 [1-8]	2 [1-8]	0.488
P/F at extubation	287 [217-359]	288 [216-366]	283 [220-348]	0.778
Use of a noninvasive method	70 (24.1)	41 (22.7)	29 (26.6)	0.480
Time between extubation and noninvasive method implementation, hours	1 [0-12]	4 [0-23]	0 [0-7]	0.009
NIV used	33 (11.4)	23 (12.7)	10 (9.2)	0.146
Indication of NIV				0.402
Prophylactic	10 (3.4)	8 (4.4)	2 (1.8)
Supportive	15 (5.2)	9 (5.0)	6 (5.5)
Other/not available	8 (2.7)	6 (3.3)	2 (1.8)
HFO used	49 (16.9)	25 (13.8)	24 (22.0)	0.039
Indication of HFO				0.085
Prophylactic	20 (6.9)	7 (3.9)	13 (11.9)
Supportive	29 (10.0)	18 (9.9)	11 (10.1)
Combination of NIV and HFO	12 (4.1)	7 (3.9)	5 (4.6)	0.768

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ARDS, acute respiratory distress syndrome; BMI, body mass index; COPD, chronic obstructive pulmonary disease; HFO, High-flow oxygenation; ICU, intensive care unit; NIV, noninvasive ventilation; OSA, obstructive sleep apnea; P1, Phase 1; P2, Phase 2; P/F, arterial partial pressure of oxygen (PaO2 in mmHg)/Fraction of inspired oxygen (FiO₂); SAPS, Simplified Acute Physiology Score.

n = percentage of group.

The proportions of patients who received a noninvasive ventilation method were not significantly different between the two cohort phases (P1 [22.7%]; P2 [26.6%]; p = 0.480). The indication of noninvasive method was listed as prophylactic in 4.5% and 5.2% of patients in P1 and P2, respectively (p = 0.099). However, the noninvasive method was implemented significantly earlier after extubation in P2 (0 [0–7] versus 4 [0–23] hours; p = 0.009). HFO was used significantly more in P2 (83% of patients receiving a noninvasive method) versus 61% in P1 (p = 0.039; Table 1). NIV was preferentially prescribed as hour-long sessions, several times a day, whereas HFO was used almost continuously with an increase in daily HFO time initiated between the two phases (13.5 [7.0–18.7] versus 20.9 [17.7–22.5] hours per day per treated patient; p = 0.001; S1 Table). Based on these results, we confirmed a change for the use of noninvasive methods between the two periods with an earlier implementation of and extended post-extubation use of HFO in the second period (P2).

Primary outcomes

In total, 24 patients (8.3%) were reintubated within the first 48 hours of extubation. The reintubation rate was significantly lower at 48 hours in the second phase of our cohort (20 [11.0%] versus 4 [3.7%] reintubations in P1 and P2, respectively; p = 0.028; Table 2).

Table 2. Patient outcomes.

Outcomes	All (n = 290)	P1 (n = 181)	P2 (n = 109)	p-value
Reintubation within 48 hours^a, %	24 (8.3)	20 (11.0)	4 (3.7)	0.028
Cause at 48 hours ^a				0.372
Acute respiratory failure	17 (5.9)	13 (7.2)	4 (3.7)
Shock/cardiac arrest	2 (0.7)	2 (1.1)	0
Neurologic failure	5 (1.7)	5 (2.8)	0
Reintubation within 7 days ^b	40 (13.8)	30 (16.6)	10 (9.2)	0.082
Cause at 7 days ^b				0.929
Acute respiratory failure	28 (9.7)	21 (11.6)	7 (6.4)
Shock/cardiac arrest	3 (1.0)	2 (1.1)	1 (0.9)
Neurologic failure	9 (3.1)	7 (3.9)	2 (1.8)
Time to reintubation, days	1 [0-3]	1 [0-3]	3 [1-5]	0.089
Days without ventilation on day 28 ^c	24.0 [17.0–26.0]	24.0 [17.0–26.0]	24.0 [18.0–26.0]	0.231
ICU length of stay, days	8.0 [4.0–17.0]	8.0 [4.0–18.0]	8.0 [4.0–17.0]	0.766
28-days mortality, %	16 (5.5)	11 (6.1)	5 (4.6)	0.792

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ICU, intensive care unit; P1, Phase 1; P2, Phase 2.

^a Reintubation within 48 hours after extubation (excluding reintubation for surgery).

^b Reintubation within 7 days after extubation (excluding reintubation for surgery).

^c Value of 0 was affected if patient died during the 28 days after extubation.

n = percentage of group.

Multivariable analysis

We conducted a multivariate analysis to explore the factors associated with successful extubation at 48 hours (Table 3). Considering the study variables that may influence successful extubation (patient comatose at admission, shock at admission, postoperative admission, and use of noninvasive ventilation method), Phase 2 was independently associated with less reintubations at 48 hours (OR 0.30 [95% CI: 0.08–0.92]; p = 0.034). This finding implies that changes in our usage of noninvasive methods between the two periods were not accompanied by a significant increase in the reintubation rate at 48 hours.

Table 3. Multivariate analysis of factors associated with reintubation within 48 hours, integrating study phase.

Characteristics	Reintubation at 48 hours^a (n = 24)	Extubation Success (n = 266)	Univariate P-value	Multivariate Regression OR [95%CI] ^b	p-value
Male sex	16 (66.7)	174 (65.4)	1.000	-
Age, years	64 [54-73]	65 [50-74]	0.949	-
BMI	26.9 [24.4–33.2]	26.7 [22.5–30.3]	0.519	-
SAPS II	45 [36-55]	48 [38-59]	0.218	-
Medical history
COPD	3 (12.5)	17 (6.4)	0.223	-
OSA	1 (4.2)	18 (6.8)	1.000	-
Arterial Hypertension	12 (50.0)	118 (44.4)	0.670	-
Coronary artery disease	1 (4.2)	25 (9.4)	0.708	-
Reason for ICU admission
Pneumonia	1 (4.2)	33 (12.4)	0.331	-
Acute pulmonary edema	0	3 (1.1)	1.000	-
ARDS	0	13 (4.9)	0.610	-
Coma	12 (50.0)	84 (31.6)	0.074	2.36 [0.88–6.56]	0.086
Shock	3 (12.5)	92 (34.6)	0.039	0.47 [0.10–1.61]	0.240
Postoperative admission	21 (52.5)	170 (70.0)	0.044	0.76 [0.30–2.00]	0.577
Postoperative day	0 [0-0]	0 [0-0]	0.518	-
P/F at admission	269 [184–377]	293 [169–401]	0.571	-
Extubation day	3 [1-17]	2 [1-8]	0.262	-
P/F at extubation	275 [206-337]	288 [218-366]	0.346	-
Phase 2	4 (16.7)	105 (39.5)	0.028	0.30 [0.08–0.92]	0.034
Prophylactic strategy	4 (16.7)	24 (9.0)	0.268
Noninvasive method			<0.001		0.013
None	15 (62.5)	205 (77.1)	Reference	-	-
NIV alone	2 (8.3)	19 (7.4)	0.065	1.46 [0.20–6.73]	0.663
HFO alone	2 (8.3)	35 (13.2)	0.750	0.90 [0.13–3.85]	0.897
Combination	5 (20.8)	7 (2.6)	<0.001	15.18 [2.78–83.16]	0.001

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ARDS, acute respiratory distress syndrome; BMI, body mass index; COPD, chronic obstructive pulmonary disease; HFO, high-flow oxygen; ICU, intensive care unit; NIV, noninvasive ventilation; OSA, obstructive sleep apnea; P/F, arterial partial pressure of oxygen (PaO₂)/Fraction of inspired oxygen (FiO₂); SAPS, Simplified Acute Physiology Score.

^a Reintubation during 48 post-extubation hours (excluding reintubation for surgery).

^bOdds ratio [95% Confidence Interval].

n = percentage of phase.

Secondary outcomes

Forty patients (13.8%) were reintubated within the first 7 days after extubation. The main cause of reintubation in both phases was the occurrence of ARF (70% of reintubated patients in both phases). The median time to reintubation was not significantly earlier in P1 (1 [0–3] day versus 3 [1–5] for P1 and P2, respectively; p = 0.089). The reintubation rate at 7 days was not significantly different between the two phases (30 [16.6%] versus 10 [9.2%] for P1 and P2, respectively; p = 0.082; Table 2). We conducted a multivariate analysis to explore the factors associated with reintubation within 7 post extubation days. The results showed that the study period was not independently associated with extubation failure during the first 7 days (OR 0.47 [CI: 0.18–1.09]; p = 0.093; S2 Table). Results observed at 48 hours were comparable to those at 7 days post extubation. There was not a significant increase in the reintubation rate in P2. Considering the factors that could influence successful extubation, this study period was not associated with reintubation.

The probability of reintubation censored at 7 days was not different between the two phases (adjusted hazard ratio of extubation failure in Phase 2 was 0.47 [95% CI: 0.22–1.04]; p = 0.061; Fig 2). The survival analyses calculated with an adjusted multivariable Cox model were not different between the two phases (S3 Table).

Fig 2 — P-value obtained with the log-rank test.

The use of noninvasive methods was independently associated with reintubation during the first 48 hours but not during the 7 days post extubation (p = 0.013 and p = 0.104, respectively; Table 3 and S2 Table). Reintubation was not specifically associated with either method when used alone (HFO alone versus NIV alone) at both 48 hours and at 7 days post extubation. However, after multivariable analysis and adjustment, the combined use of NIV and HFO in the same patients was independently associated with increased extubation failure during the first 48 hours (OR 15.18 [95% CI: 2.78–83.16]; p = 0.001; Table 3). This association between the combined use of NIV and HFO and increased extubation failure was also found during the first 7 days (OR 6.70 [95% CI: 1.46–31.43]; p = 0.013; S2 Table). The details of the combined use of NIV and HFO are presented in the S4 Table.

Finally, none of the other primary clinical outcomes (day-28 mortality, ICU length of stay, and ventilation-free days) were notably different between the two phases (Table 2).

Discussion

In this single-center retrospective cohort study, we confirmed the safety of a practice change in the use of noninvasive methods, with the earlier and more extended post-extubation use of HFO in P2. This confirmation was not accompanied by a significant increase in the reintubation rate at neither 48 hours nor at 7 days, post extubation. Adjustments of factors that could influence successful extubation were conducted and the results revealed no association between extubation failure and the second phase of the study. Use of noninvasive methods has traditionally raised safety concerns [23], mainly due to the potentially increased risk of poorer outcomes resulting from delayed reintubation. Our results do not seem to support these concerns. The median time to reintubation tended to be earlier in P1 (1 [0–3] versus 3 [1–5] days in P1 and P2, respectively; p = 0.089), with no difference in 28-day mortality (p = 0.792), ICU length of stay (p = 0.766), or days without ventilation (p = 0.231).

Studies comparing data on NIV and HFO are available; however, they are inconclusive about oxygenation, work of breathing, and need for intubation [26]. In a randomized controlled trial, Hernandez et al. [20] showed that in a mix of high-risk medical and surgical, post-extubation patients, HFO was similar to NIV in the prevention of reintubation and post-extubation respiratory failure. In another randomized controlled trial with cardiothoracic surgical patients, with or at risk for ARF, Stéphan et al. [21] showed that the use of continuous HFO did not result in higher rates of treatment failure than did intermittent NIV (reintubation in 14.0% versus 13.7%; p = 0.99). Results of previous published studies were pooled in a meta-analysis comparing the effects of HFO and NIV after extubation, and there was no significant difference in the rates of treatment failure (OR 0.96 [95% CI: 0.75–1.24]; p = 0.77) and reintubation (OR 1.00 [95% CI: 0.76–1.32]; p = 0.98) [21].

We chose to assess the reintubation rate at 48 hours as a safety endpoint because extubation failure is currently defined as the need to reintubate within 48 hours after extubation [8,9]. In our study, the overall post-extubation rate in ARF within 48 hours was approximately 8%, which is similar to the overall rate reported at 48–72 hours in previous randomized trials assessing noninvasive methods [3,19]. The rate of reintubation due to non-respiratory causes was greater than 30% in our study. However, this finding is probably related to the high proportion of brain injury patients in our ICU population (33.1% of comatose patients at admission). In these patients, reintubation for neurological failure is obviously more frequent [7]. Furthermore, in the context of neurological failure, the use of a noninvasive method is unlikely to prevent reintubation (22.5% of reintubations were for neurologic failure). Patient selection with less risk factors for neurologic failure should be considered to potentially maximize the benefit of noninvasive methods to prevent reintubation.

In our study, we observed a decrease of 70% in the reintubation rate at 48 hours after extubation, but not at 7 days. Indeed, the reintubation rate we observed at 7 days (13.8% overall) was similar to those reported in previous studies [27]. Recently, Thille et al. proposed to extend the definition of extubation failure to 7 days after extubation when using noninvasive methods [28]. Our results suggest that an evaluation of extubation failure at 7 days is more clinically appropriate than at 48 hours.

In our cohort, HFO therapy lasted longer than NIV (daily therapy duration and number of days). This may be related to a poorer tolerance of NIV than HFO and improved comfort under HFO [3]. Patient care can be improved through increased respiratory comfort; however, these factors were not extensively evaluated in our study, warranting the need for future research.

The combination of NIV and HFO has been proposed to prevent post-extubation ARF. Thille et al. [27] showed that the combination of NIV and HFO after extubation significantly decreased the risk of reintubation compared to HFO alone. We observed that the reintubation rate independently increased in the subgroup of patients treated with a combination of NIV and HFO (OR 15.18 (95% CI:2.78–83.16]; p = 0.001; Table 3). The proportion of surgical patients was higher in our cohort. The differences in the pathophysiology of ARF between surgical and medical patients could be partially explained by this discrepancy. In our cohort, the combined use of NIV and HFO was low (4.1%) in both phases. We can assume that the combination of therapy was used on the more serious patients, explaining the increase in extubation failure in this sub-group. The small number of patients does not allow for definitive conclusions about the combined use of NIV and HFO. Further studies focusing on the safety of using a combination noninvasive methods to prevent or treat ARF are needed.

To our knowledge, this is the first study to describe the safety and evolution of the use of noninvasive methods in a real-life setting. Many studies that have focused on the post-operative use of noninvasive methods were limited to the comparison of NIV and HFO; however, few have included patients who did not receive any of these methods. Lastly, in our study, physicians were free to choose the strategy they considered most appropriate. The changes in the use of non-invasive methods are therefore likely to be spontaneously observed in any ICU.

This study has several limitations. First, given the retrospective and observational design of this study, we cannot establish any causal relationship. Second, missing data about the use of noninvasive ventilation or reintubation status might have influenced the results. Third, the lack of statistical power did not allow for conclusions about our second endpoint criteria (reintubation at 7 days). Lastly, the single-center design may have exacerbated the selection bias.

Conclusions

In this single-center retrospective cohort study, earlier implementation of noninvasive ventilation methods and increased use of HFO were observed between the two phases. Reintubation rates did not increase in the first 48 hours or at 7 days post extubation with the implementation of practice changes in the post-extubation use of NIV and HFO in our surgical ICU. These results suggest that these practice changes are safe and effective.

Supporting information

S1 Table. Characteristics of use and setting of noninvasive methods.

FiO₂: Fraction inspired of oxygen. NIV: Noninvasive ventilation. HFO: High-flow oxygenation.

(DOCX)

Click here for additional data file.^{(18.2KB, docx)}

S2 Table. Multivariate analysis of factors associated with reintubation within 7 days, integrating study phase.

n (% of group). Odd ratio [95% Confidence Interval]: OR[95%IC]. BMI: Body mass index. COPD: Chronic obstructive pulmonary disease. OSA: Obstructive sleep apnea. ICU: Intensive care unit. ARDS: Acute respiratory distress syndrome. P/F: Arterial partial pressure of oxygen (PaO2 in mmHg)/Fraction inspired of oxygen (FiO₂). ^a Reintubation within 7 days after extubation (excluding reintubation for surgery).

(DOCX)

Click here for additional data file.^{(17.3KB, docx)}

S3 Table. Multivariable Cox analysis of factors associated with reintubation integrating study phase.

n (% of group). Hazard ratio [95% Confidence Interval]: HR[95%IC]. -: Not available. BMI: Body mass index. COPD: Chronic obstructive pulmonary disease. OSA: Obstructive sleep apnea. ICU: Intensive care unit. P/F: Arterial partial pressure of oxygen (PaO₂)/Fraction inspired of oxygen (FiO₂). ^a Reintubation within 7 days after extubation (excluding reintubation for surgery).

(DOCX)

Click here for additional data file.^{(17.5KB, docx)}

S4 Table. Detail of combined use of NIV and HFO.

No statistical comparisons were made due to the small number of patients.

(DOCX)

Click here for additional data file.^{(13.9KB, docx)}

S1 Data

(XLSX)

Click here for additional data file.^{(74.5KB, xlsx)}

Data Availability

All relevant data are within the paper and its Supporting Information files.

Funding Statement

The author(s) received no specific funding for this work.

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PLoS One. doi: 10.1371/journal.pone.0249035.r001

Decision Letter 0

James Andrew Rowley

19 Oct 2020

PONE-D-20-29871

Effect of changes in the use of noninvasive ventilation and high flow oxygen therapy on reintubation in a surgical intensive care unit. A Retrospective Cohort Study

PLOS ONE

Dear Dr. Abrard,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

The authors should note that one of the reviewers felt there was extensive need for editing, specifically asking for more details on study design and results. I would also add that is unclear what processes occurred between phase 1 and phase 2 that resulted in more HFO2 use: education amongst physicians? education of respiratory therapists? New protocols/policies? These need to be spelled out. Finally, as the reviewer pointed out there has been randomized studies showing no difference in outcomes between NIV and HFO2; the authors need to discuss why there results are different and whether clinically relevant given randomized trial data.

Please submit your revised manuscript by Dec 03 2020 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

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We look forward to receiving your revised manuscript.

Kind regards,

James Andrew Rowley

Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Partly

Reviewer #2: Yes

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: I Don't Know

Reviewer #2: Yes

**********

3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Is the manuscript presented in an intelligible fashion and written in standard English?

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Reviewer #1: Yes

Reviewer #2: Yes

**********

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: This paper needs to be heavily edited and revised, including adding more explanation for the difference observed between phase 1 and phase 2 and between the patients and practice improvements in phase 1 and phase 2, which would require more detail in the study design, results, and discussion. Although this study subject was very interesting and clearly involved a lot of work with data collection and analysis, this paper wasn't strong enough to change current practice, especially since there have been 2 multicenter publications showing no difference in HFO and NIV for reintubation.

Reviewer #2: Data in the abstract and data in the tables don't align or just isn't clear. For example, in the abstract the HFO use in P2 is 24 with 83% and in Table 1 P2 has 24 with percent of 22%. In looking at the table it looks like the 2nd time period had less HFO use (greater percentage is true) and then had a decreased reintubation rate at 48 hour. They stated that there was a increase in education between the 2 time groups about HFO and while statistically significant the clinical significant of 1 patient is questionable.

In addition about 30% of the patient in the study are not postoperative patients. If want to make an assessment about HFO in SICU patient population it should all be surgical or at least define where these nonoperative patients come from (i.e. are they non-operative trauma, head injury, etc.)

There are several questionable typing errors of the p being reported at p<.15 on line 143, which I'm assuming should be p<0.05?

**********

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Reviewer #1: No

Reviewer #2: No

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Attachment

Submitted filename: PLOS1 review.docx

Click here for additional data file.^{(25.8KB, docx)}

PLoS One. 2021 Mar 22;16(3):e0249035. doi: 10.1371/journal.pone.0249035.r002

Author response to Decision Letter 0

2 Dec 2020

Dear Editor,

I am pleased to submit this revised version of our manuscript (Ref: PONE-S-20-37260) entitled “Effect of changes in the use of noninvasive ventilation and high flow oxygen therapy on reintubation in a surgical intensive care unit. A Retrospective Cohort Study.” for possible publication in Plos One.

You will find below the point-by-point response to reviewers' comments. The changes are reported in red in the revised text.

We, authors of PONE-S-20-37260, thank you for your time and consideration. Reviewers’ comments helped us revise the manuscript, and we believe that content and clarity are now improved in this revised version.

Sincerely yours,

Stanislas Abrard

Attachment

Submitted filename: Response_to_review_ARVENIO.docx

Click here for additional data file.^{(41.8KB, docx)}

PLoS One. doi: 10.1371/journal.pone.0249035.r003

Decision Letter 1

James Andrew Rowley

22 Dec 2020

PONE-D-20-29871R1

Effect of changes in the use of noninvasive ventilation and high flow oxygen therapy on reintubation in a surgical intensive care unit. A Retrospective Cohort Study

PLOS ONE

Dear Dr. Abrard,

Please note two things:

1. I have reviewed Reviewer #1s detailed comments and agree that more work needs to be done for clarity.

2. Reviewer #2 reviewed your revision outside of Editorial Manager and felt that you have responded to her comments in an appropriate manner.

Therefore, key that you respond carefully to Reviewer #1.

Please submit your revised manuscript by Feb 05 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

We look forward to receiving your revised manuscript.

Kind regards,

James Andrew Rowley

Academic Editor

PLOS ONE

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #1: Partly

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

Reviewer #1: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

Reviewer #1: No

**********

6. Review Comments to the Author

Reviewer #1: see attachment for the rest of the comments. 1. There needs further revision for clarity of thought and free of grammatical errors. for example, in line 59, "pathophysiology" is not used correctly here. It is a term to describe the physiologic mechanism behind symptoms so should not be used to describe a list of clinical manifestations or symptoms. there should also be a "and" before cardiac dysfunction in line 60. In line 67, the use of the word "curative" is also odd because NIV doesn't "cure" tracheal reintubation, since it is a supportive measure to bridge until the underlying process is addressed so should be referred to as "preventative". In line 69, the phrase "a more recent method" is unclear and refers to that is a more recent developed technology compared to NIV but I think only a reader who would know that context would understand this, so instead of "recent method" should be changed to "a more recently developed technology". But that sentence doesn't clearly distinguish the difference between NIV and HFO. 2. Results section needs major revising and recommendations were given. 3. Discussion section needs major revising, especially in the context of how your results fit into the current literature especially the two meta-analyses. 4. Conclusion: needs major revising--the wording in the sentence is not only confusing but also misleading. It suggests that using earlier use of non-invasive and HFO will decrease re-intubation, but your study is not a prospective study on the timing of NIV and HFO on reintubation rates.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Attachment

Submitted filename: reviewer comment #2.docx

Click here for additional data file.^{(14.4KB, docx)}

PLoS One. 2021 Mar 22;16(3):e0249035. doi: 10.1371/journal.pone.0249035.r004

Author response to Decision Letter 1

1 Feb 2021

Reviewer #1 comments:

1. There needs further revision for clarity of thought and free of grammatical errors. for example, in line 59, "pathophysiology" is not used correctly here. It is a term to describe the physiologic mechanism behind symptoms so should not be used to describe a list of clinical manifestations or symptoms. there should also be a "and" before cardiac dysfunction in line 60.

An Editing Service edited this manuscript. We replaced « pathophysiology » in line 59 by « causes ».

In line 67, the use of the word "curative" is also odd because NIV doesn't "cure" tracheal reintubation, since it is a supportive measure to bridge until the underlying process is addressed so should be referred to as "preventative".

Thank you for allowing us to clarify this point. Of course, the NIV does not treat tracheal intubation. We wanted to differentiate between two situations well described by the guidelines (Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Bram Rochwerg et al. Eur Resp J 2017): NIV for treatment of ARF in prevention of reintubation (patient with ARF criteria) named “curative” NIV in our previous manuscript and NIV for prevent post-extubation ARF (patient without AFR criteria) named “preventive” NIV in our previous manuscript. To improve clarity of our manuscript, in the revised version we named “prophylactic” NIV for prevent post-extubation ARF (patient without AFR criteria) and “supportive treatment by NIV” NIV for treatment of ARF in prevention of reintubation (patient with ARF criteria) to bridge until the underlying process.

In line 69, the phrase "a more recent method" is unclear and refers to that is a more recent developed technology compared to NIV but I think only a reader who would know that context would understand this, so instead of "recent method" should be changed to "a more recently developed technology". But that sentence doesn't clearly distinguish the difference between NIV and HFO.

This term has been changed and precisions have been added.

In lines 83 & 84, connect the reason to your unit's change in practice more clearly to the benefits as described in lines 73. Also, it would be more clear to define specific worsening outcomes in line 79, because patient safety should then be addressed as part of your primary objectives and results. In light of the two meta-analyses and studies of prospective randomized controlled studies, at the most your retrospective study can show no worsening of patients but would not be able to prove HFO is superior.

The benefits described in the introduction have been more clearly linked to the reason of our unit practice changes.

The introduction and discussion paragraphs have been greatly revised regarding patient safety during this change in practice and no worsening.

In line 109, this sentence "we proceeded to anonymization of database before data analysis" is awkwardly phrased and needs re-writing.

This sentence has been reformulated.

Line 113 the term "extubated alive" is a strange phrase. Would recommend removing "alive". Does this mean patients who were deceased post-re-intubation were excluded? If so, this would potentially skew your results to showing falsely favorable outcomes because the poor outcomes were already removed from analysis, therefore needs to be stated as a major limitation of the study.

We have removing the term “alive”. No, only patients deceased before an first extubation were excluded (never extubated).

The line 122-126 is also awkwardly phrased and need re-writing.

These sentences have been reformulated.

Line 128-131 needs re-writing for clarity. e.g. secondary endpoints included the reintubation rate on day 7 post-extubation,....

These sentences have been reformulated.

In line 220, “in respectively” is a phrase that doen’t make sense grammatically.

This sentence has been reformulated.

Line 222, “at 7th day” also is a strange phrase-better to say “with maintaining successful extubation by post-extubation day 7.”

This sentence has been reformulated.

Line 224-226 was confusingly and the point was lost. Please re-phrase.

These sentences have been reformulated.

Line 237 to 239, it is not enough to say “there is an association” between this and extubation failure but you need to explicitly say and interpret for the reader what the association is actually meaning (you state this in your discussion section but need to write something in the results too), with context of your variables.

These sentences have been reformulated.

2. In the discussion section, you need to refer to the primary objective which is determining the re-intubation rates with the change in practice but also if the change in practice caused a null, positive, or negative impact on patient care. A lot of the first paragraph are sentences that should be in the result section. The discussion should start by discussing how your main results are meeting or not meeting your objective and the societal or patient impact of your results, such as how you go into this in your second paragraph.

The conclusion has been entirely rewrite following your advices.

Line 271, you wrote “specifically associated specifically”. This sentence needs to be re-written.

This sentence has been rewrite.

Line 273, “the” needs to be inserted before combination.

Modified

Discussion section needs major revising, especially in the context of how your results fit into the current literature especially the two meta-analyses.

Please go through the discussion more thoroughly with significant revision and editing.

The discussion paragraph has been greatly revised integrating the two meta-analyses and edited by an Editing Service.

3. Conclusion: needs re-writing for clarity and grammar. This sentence suggests a though as derived from the paper, but has to be able to stand alone so that a reader would understand the main point of the paper prior to reading the details in the paper. I think the main point is actually there were no worsened re-intubation rates with the change of practice of increasing the use of HFO and NIV post-extubation in a surgical icu. The wording in the sentence is not only confusing but also misleading. It suggests that using earlier use of non-invasive and HFO will decrease re-intubation, but your study is not a prospective study on the timing of NIV and HFO on reintubation rates.

The conclusion has been entirely rewrite following your advices.

Attachment

Submitted filename: Response_to_review2_ARVENIO.docx

Click here for additional data file.^{(17.8KB, docx)}

PLoS One. doi: 10.1371/journal.pone.0249035.r005

Decision Letter 2

Yu Ru Kou

15 Feb 2021

PONE-D-20-29871R2

Safety of changes in the use of noninvasive ventilation and high flow oxygen therapy on reintubation in a surgical intensive care unit:A retrospective cohort study

PLOS ONE

Dear Dr. Abrard,

The reviewer still raised some issues that required to be addressed.

Please submit your revised manuscript by Apr 01 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

We look forward to receiving your revised manuscript.

Kind regards,

Yu Ru Kou, PhD

Academic Editor

PLOS ONE

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

Reviewer #1: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #1: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

Reviewer #1: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

Reviewer #1: Yes

**********

6. Review Comments to the Author

Reviewer #1: This draft has significantly improved. There are still a few areas of ambiguous language that require clarification:

1.Line 248 to 252: The authors stated there was an association between the combination of NIV and HFO with extubation failure. For the ease of the reader, it would be better to qualify this association such as adding “increased” before “extubation failure” in line 249 and again adding "increased" before extubation in line 251.

2. Line 292-294: Recommend to rephrase this because the meaning was unclear. I am guessing on authors' intention, but one suggestion could be: “The underlying causes of neurologic failure or shock vary so not all of the contributing factors were included, such as over-sedation causing hypercapnia or hypovolemia causing shock. Patient selection with less risk factors for neurologic failure or shock should be considered to potentially maximize the benefit of noninvasive methods to prevent reintubation.”

3. Line 313: The phrase “without evolution over the phases” was confusing. Can the authors instead of this phrase just state more simply “in both phases.”

4. Line 314: The phrase “proposed to the more serious patients” may not be quite accurate, because proposed means to suggest but did not actually employ this method. Instead, are the authors meaning “used on the more serious patients.”

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: Sarah J. Lee

PLoS One. 2021 Mar 22;16(3):e0249035. doi: 10.1371/journal.pone.0249035.r006

Author response to Decision Letter 2

17 Feb 2021

Dear Editor,

I am pleased to submit this revised version of our manuscript (Ref: PONE-S-20-29871R3) entitled “Safety of changes in the use of noninvasive ventilation and high flow oxygen therapy on reintubation in a surgical intensive care unit: A retrospective cohort study.” for possible publication in Plos One.

You will find below the point-by-point response to reviewers' comments. The changes are reported in red in the revised text.

Sincerely yours,

Stanislas Abrard

Q 1.Line 248 to 252: The authors stated there was an association between the combination of NIV and HFO with extubation failure. For the ease of the reader, it would be better to qualify this association such as adding “increased” before “extubation failure” in line 249 and again adding "increased" before extubation in line 251.

A: Thank to this comment. We have adding "increased" before "extubation" in lines 249 and 251.

Q 2. Line 292-294: Recommend to rephrase this because the meaning was unclear. I am guessing on authors' intention, but one suggestion could be: “The underlying causes of neurologic failure or shock vary so not all of the contributing factors were included, such as over-sedation causing hypercapnia or hypovolemia causing shock. Patient selection with less risk factors for neurologic failure or shock should be considered to potentially maximize the benefit of noninvasive methods to prevent reintubation.”

A: Thank you for your suggestion.

Q 3. Line 313: The phrase “without evolution over the phases” was confusing. Can the authors instead of this phrase just state more simply “in both phases.”

A: We have made the change.

Q 4. Line 314: The phrase “proposed to the more serious patients” may not be quite accurate, because proposed means to suggest but did not actually employ this method. Instead, are the authors meaning “used on the more serious patients.”

A: We have made the change.

PLoS One. doi: 10.1371/journal.pone.0249035.r007

Decision Letter 3

Yu Ru Kou

2 Mar 2021

PONE-D-20-29871R3

Safety of changes in the use of noninvasive ventilation and high flow oxygen therapy on reintubation in a surgical intensive care unit: A retrospective cohort study

PLOS ONE

Dear Dr. Abrard,

The reviewer had one minor editorial suggestion.

Please submit your revised manuscript by Apr 16 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

We look forward to receiving your revised manuscript.

Kind regards,

Yu Ru Kou, PhD

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

Reviewer #1: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #1: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

Reviewer #1: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

Reviewer #1: Yes

**********

6. Review Comments to the Author

Reviewer #1: Recommend removing the sentence in lines 292-294 "The underlying causes of neurologic failure or shock vary so not all of the contributing factors were included, such as over-sedation causing hypercapnia or hypovolemia causing shock." This sentence's grammar and meaning are still unclear.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

PLoS One. 2021 Mar 22;16(3):e0249035. doi: 10.1371/journal.pone.0249035.r008

Author response to Decision Letter 3

8 Mar 2021

Answer: This sentence has been deleted.

PLoS One. doi: 10.1371/journal.pone.0249035.r009

Decision Letter 4

Yu Ru Kou

10 Mar 2021

Safety of changes in the use of noninvasive ventilation and high flow oxygen therapy on reintubation in a surgical intensive care unit: A retrospective cohort study

PONE-D-20-29871R4

Dear Dr. Abrard,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Yu Ru Kou, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

PLoS One. doi: 10.1371/journal.pone.0249035.r010

Acceptance letter

Yu Ru Kou

12 Mar 2021

PONE-D-20-29871R4

Safety of changes in the use of noninvasive ventilation and high flow oxygen therapy on reintubation in a surgical intensive care unit: A retrospective cohort study

Dear Dr. Abrard:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Yu Ru Kou

Academic Editor

PLOS ONE

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

S1 Table. Characteristics of use and setting of noninvasive methods.

FiO₂: Fraction inspired of oxygen. NIV: Noninvasive ventilation. HFO: High-flow oxygenation.

(DOCX)

Click here for additional data file.^{(18.2KB, docx)}

S2 Table. Multivariate analysis of factors associated with reintubation within 7 days, integrating study phase.

(DOCX)

Click here for additional data file.^{(17.3KB, docx)}

S3 Table. Multivariable Cox analysis of factors associated with reintubation integrating study phase.

(DOCX)

Click here for additional data file.^{(17.5KB, docx)}

S4 Table. Detail of combined use of NIV and HFO.

No statistical comparisons were made due to the small number of patients.

(DOCX)

Click here for additional data file.^{(13.9KB, docx)}

S1 Data

(XLSX)

Click here for additional data file.^{(74.5KB, xlsx)}

Attachment

Submitted filename: PLOS1 review.docx

Click here for additional data file.^{(25.8KB, docx)}

Attachment

Submitted filename: Response_to_review_ARVENIO.docx

Click here for additional data file.^{(41.8KB, docx)}

Attachment

Submitted filename: reviewer comment #2.docx

Click here for additional data file.^{(14.4KB, docx)}

Attachment

Submitted filename: Response_to_review2_ARVENIO.docx

Click here for additional data file.^{(17.8KB, docx)}

Data Availability Statement

All relevant data are within the paper and its Supporting Information files.

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PERMALINK

Safety of changes in the use of noninvasive ventilation and high flow oxygen therapy on reintubation in a surgical intensive care unit: A retrospective cohort study

Stanislas Abrard

Lorine Jean

Emmanuel Rineau

Pauline Dupré

Maxime Léger

Sigismond Lasocki

Roles

Abstract

Introduction

Methods

Study design and setting

Participants

Variables

Statistical analysis

Results

Study participants

Fig 1. Cohort selection flow chart.

Table 1. Baseline patient characteristics.

Primary outcomes

Table 2. Patient outcomes.

Multivariable analysis

Table 3. Multivariate analysis of factors associated with reintubation within 48 hours, integrating study phase.

Secondary outcomes

Fig 2. Kaplan–Meier curves showing extubation success within 7 days according to study phase.

Discussion

Conclusions

Supporting information

Data Availability

Funding Statement

References

Decision Letter 0

James Andrew Rowley

Roles

Author response to Decision Letter 0

Decision Letter 1

James Andrew Rowley

Roles

Author response to Decision Letter 1

Decision Letter 2

Yu Ru Kou

Roles

Author response to Decision Letter 2

Decision Letter 3

Yu Ru Kou

Roles

Author response to Decision Letter 3

Decision Letter 4

Yu Ru Kou

Roles

Acceptance letter

Yu Ru Kou

Roles

Associated Data

Supplementary Materials

Data Availability Statement

ACTIONS

PERMALINK

RESOURCES

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