Abstract
Background and Aims:
Endotracheal intubation (ETI) in the intensive care unit (ICU) carries significant risks. Peri-intubation care bundles have been shown to reduce severe complications associated with ETI, but they are not routinely implemented due to equipment, drug shortages, and changes in local policies. Therefore, we developed an intubation bundle and assessed its impact on complications.
Methods:
This study was carried out over 18 months with adult patients requiring ETI in the ICU. The intubation practices and complication rates were evaluated during the pre-implementation phase (Phase I). The ETI bundle was developed based on an analysis of these complications and existing guidelines, and the ICU team was trained on its application. Afterwards, complications during ETI were documented in the post-implementation phase to evaluate the impact of the intubation bundle (Phase II). P values < 0.05 were considered statistically significant.
Results:
The number of patients with major complications decreased significantly after the introduction of the bundle (45% vs 29%, P < 0.001). Critical haemodynamic instability (HI) was the primary complication, and the use of a bundle was associated with a significant reduction (39% vs 19%, P < 0.001). Additionally, by implementing the bundle led to significant improvements in intubation practices, such as airway assessment by the MACOCHA score, optimisation of patient positioning, and the presence of two intubators.
Conclusion:
Our study demonstrates that implementing an intubation bundle in ICU settings makes ETI practices safer by decreasing the incidence of life-threatening complications.
Keywords: Airway evaluation, airway management, endotracheal intubation, haemodynamic instability, intensive care unit, intubation bundle, intubation complications, MACOCHA score
INTRODUCTION
Endotracheal intubation (ETI) is a common procedure performed in the intensive care unit (ICU) for indications such as respiratory failure, airway protection, hypoxia, and increased work of breathing.[1] Contrary to the operating room patients, ICU patients are often critically ill and have physiologically difficult airways due to underlying hypoxaemia, hypotension, metabolic and respiratory derangements.[2] This seminal procedure carries high risk, and careful airway management practice is crucial, as complications during ETI might significantly worsen the outcomes of critically ill patients.
The Fourth National Audit Project (NAP4) of the Royal College of Anaesthetists and the Difficult Airway Society reported a high incidence of mortality related to ETI in ICU settings. It noted that these complications can be reduced by taking adequate precautions.[3] Implementation of peri-intubation care bundles has been shown to reduce the incidence of severe complications associated with ETI.[4] Anaesthesia and critical care societies also recommend intubation checklists and algorithms to address the complications during ETI.[1,5] In the multicentre INTUBE study, the authors observed that standard intubation protocols were used in only half of the study population, and they noted that major life-threatening complications occurred in 45% of the study population.[6]
Despite existing evidence, the implementation of these guidelines is not uniform across ICUs, as the practices differ based on local policies and equipment availability. There is an array of sedatives and paralytics that can be used for ETI, and the preferences vary across individual sites. Additionally, equipment such as video laryngoscopy and waveform capnography might be lacking in many ICU settings. Therefore, we conducted this before-and-after study to assess the practices of ETI and record the incidence of complications during emergency tracheal intubation. The primary objective of the study was to assess the impact of an intubation bundle on the incidence of major complications during the peri-intubation period. The secondary objectives of the study were to assess the impact of an intubation bundle on the incidence of minor complications and mortality of ICU patients. We hypothesised that implementation of the ETI bundle would reduce the incidence of major and minor complications, including mortality.
METHODS
This study was conducted in the 32-bed ICU of our tertiary care teaching hospital from April 2023 to September 2024, following a quasi-experimental before-after study design. The study was started after obtaining clearance from the Institutional Ethical Committee (vide approval number IEC1: 307/2022, dated 09/02/2023), and the trial was registered with the Clinical Trials Registry - India (vide approval number CTRI/2023/03/064788, dated 29/03/2023, accessible at https://www.ctri.nic.in).
Patients aged 18 years or older requiring ETI were included in the study. Patients’ relatives who did not consent to the study, as well as those undergoing intubations during cardiac arrest and patients requiring re-intubation or tube change, were excluded from the study. Written informed consent was obtained for participation in the study and for the use of the patient data for research and educational purposes. The study was carried out in accordance with the principles of the Declaration of Helsinki (2013 and Good Clinical Practice guidelines.
The tracheal intubation practice and the incidence of complications during ETI were assessed in the initial 8 months of the pre-implementation period. Over the next 2 months, the ETI bundle was prepared, and the ICU team was educated on the implementation of an intubation bundle. Subsequently, complications during ETI were recorded in the post-implementation period over 8 months [Figure 1]. During the study’s initial observation phase (Phase I), all the consecutive ICU patients meeting the study criteria were included in the study. The intubation procedure was performed in the ICU, and the patient’s demographic data were noted in detail. Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation 2 (APACHE 2) scores were noted on the day of ETI.[7,8] Charleson Comorbidity Index (CCI),[9] type of admission, urgency of ETI, and an indication of ETI were recorded. A note was made regarding the patient’s airway assessment, intubation practices, and ETI characteristics. The patient’s vitals were monitored to look for the incidence of life-threatening complications occurring within 60 minutes of intubation. The operational definitions are mentioned in Table 1. Other peri-intubation complications occurring during tracheal intubation, such as difficult intubation, oesophageal intubation, aspiration of gastric content, cardiac arrhythmias, and dental injuries, were also recorded. The healthcare professionals were blinded to the study’s conduct during Phase I, and data regarding ETI were collected from the patient’s files, records, and monitors, which healthcare professionals then recalled. Phase I was conducted over 8 months.
Figure 1.
Study flow diagram. ETI = Endotracheal intubation
Table 1.
Operational definition
| Terminology | Definition |
|---|---|
| Major Complications •Critical haemodynamic instability •Severe hypoxia •Cardiac arrest |
•SBP <65 mmHg, new/increased requirements of vasopressor by more than 50%, and the requirement of >10 mL/kg IV fluid bolus post-intubation. •Saturation on finger pulse oximetry below 80% •Cardiac arrest occurring during or within 60 minutes of ETI |
| Minor Complications •Difficult intubation •Oesophageal intubation •Aspiration of gastric content •Cardiac arrhythmias •Dental injury |
•≥3 attempts at ETI/more than 10 minutes of using conventional laryngoscopy/the need for another operator •Placement of the endotracheal tube in the oesophagus identified by capnography/auscultation •Migration of stomach contents into the lung •Supraventricular and/or ventricular arrhythmia that required therapy •Bleeding from gums and loss of teeth |
| •Difficult airway prediction | •MACOCHA Score≥3 |
| Intubation urgency •Immediate •Relative •Deferred |
•Immediate requirement of intubation •Intubation was decided and carried out within <1 h •Intubations were done electively after >1 h of decision |
| Intubator experience •Junior resident •Senior resident •Consultant |
•1–3 years •3–5 years •>5 years |
ETI=endotracheal intubation; IV=intravenous; SBP=systolic blood pressure
Based on the data analysis in Phase I, the most common complication-related factors were identified and analysed [Supplementary Table 1]. An intubation bundle was prepared based on the factors associated with complications and the existing evidence regarding emergency intubation in ICU settings. The bundle prepared was validated by five senior ICU physicians for its content and context. Based on the feedback, the bundle was further modified before its introduction for clinical use [Supplementary Table 2]. The bundle was used for the formal education and training of all the healthcare professionals involved in ICU patient care. The educational training was conducted over 1 month through classroom teaching and bedside discussions. Healthcare professionals were sensitised regarding the various components of the bundle, and the training was repeated every month to reinforce the bundle. The bundle was kept in all the ICU airway trolleys for reference during subsequent ETIs.
Supplementary Table 1.
Factors associated with severe complications
| Patients with major complications |
P | |||
|---|---|---|---|---|
| No (111) | Yes (91) | |||
| CCI | 3 (1–5) | 3 (1–5) | 0.6 | |
| Intubation urgency | Immediate requirement | 12 (39) | 19 (61) | 0.06 |
| <1 h | 75 (61) | 48 (39) | ||
| >1 h | 24 (50) | 24 (50) | ||
| Intubator experience | Junior resident | 67 (55) | 54 (45) | 0.9 |
| Senior resident | 37 (54) | 33 (46) | ||
| Consultant | 7 (58) | 5 (42) | ||
| Vasopressor pre-intubation | No | 106 (70) | 46 (30) | <0.001 |
| Yes | 5 (10) | 45 (90) | ||
| Intubation difficulty Cormack-Lehane Grade |
I | 37 (63) | 22 (37) | 0.01 |
| II | 61 (53) | 55 (47) | ||
| III | 12 (75) | 4 (25) | ||
| IV | 1 (100) | 0 | ||
| MACOCHA Scoring |
<=3 | 37 (62) | 33 (38) | 0.39 |
| >3 | 46 (54) | 39 (46) | ||
| NA | 28 (49) | 29 (51) | ||
| SOFA score | 7 (6-9) | 8 (7-11) | 0.01 | |
| APACHE II score | 19 (13-22) | 21 (16-26) | 0.02 | |
Data expressed as number (percentage) or median (interquartile range). APACHE 2=Acute Physiology and Chronic Health Evaluation 2 score; CCI=Charlson Comorbidity Index; SOFA=Sequential organ failure assessment
Supplementary Table 2.
Intubation bundle
| Pre-intubation | During intubation | Post intubation |
|---|---|---|
| ➢Equipment Check ߛ All monitors applied (SpO2, ETCO2, ECG, NIBP/IBP) ߛ Working suction Self-inflating bag ߛ Tracheal tubes, check cuff and stylet ߛ Direct laryngoscopes, working X 2 sets ߛ Gudel/nasal airways ߛ Bougie ߛ Supraglottic airway device ߛ Video laryngoscope as a standby ߛ FONA set ➢ Patient check ߛ Reliable IV access secured, and maintenance fluid started ߛ Airway assessment- MACOCHA score ߛ Patient position optimised ߛ If BP is low, use fluids and load vasopressors ߛ Pre-oxygenation 3 min 100% FiO2, preferably by CPAP/NIV ߛ Aspirate NG tube ߛ Check labs- potassium ➢ Check the drugs ߛ Sedative (fentanyl, midazolam, ketamine, etomidate) ߛ Relaxant (succinylcholine, rocuronium) ߛ Vasopressors (load noradrenaline if low BP anticipated) ߛ Maintenance sedation agent to be loaded ߛ Emergency cart mobilised ߛ Verbalise the airway plan and allot roles ߛ Time recording person |
ߛ Ensure the presence of another intubator ߛ Rapid sequence intubation ߛ Sellick manoeuvre ➢ Plan A ߛ Drugs and Laryngoscopy ߛ Maximum three attempts ߛ Use adjuncts if required ߛ Use video laryngoscopy if required ➢ Plan B/C ߛ Supraglottic airway ߛ Face mask ߛ Fibreoptic intubation via supraglottic airway ➢ Plan D ߛ Front-of-neck airway |
ߛ Immediate confirmation of endotracheal tube by capnography ߛ Nor-epinephrine if MAP remains below 50 mmHg ߛ Initiate long-term sedation ߛ Lung protective ventilatory strategy ߛ Chest x ray ߛ ABG ߛ Debriefing session |
ABG=arterial blood gas; BP=blood pressure; CPAP=continuous positive airway pressure; ETCO2=end-tidal carbon dioxide; ECG=electro cardiogram; NIBP=non-invasive blood pressure; IBP=invasive blood pressure; FONA=front of neck access; IV=intravenous; MAP=mean arterial pressure; NG=Nasogastric; NIV=non-invasive ventilation
During the implementation period (Phase II), the bundle was introduced during ETI, and peri-intubation practices and complications occurring within 60 minutes of ETI were recorded, as in Phase I. Post-ETI, a debrief session was conducted to provide continued education and emphasise adherence to all components of the bundle in Phase II. This intervention period lasted 8 months.
As the primary outcome, the incidence of major complications (critical haemodynamic instability (HI), severe hypoxia, and cardiac arrest) during the ETI was compared before and after the implementation of the intubation bundle. As secondary outcomes, the incidence of minor complications (oral injury, oesophageal intubation, gastric aspiration, and arrhythmia) during ETI and the 28-day mortality rate were compared before and after the implementation of the intubation bundle.
Statistical Package for the Social Sciences (SPSS) version 29.0 for Windows (International Business Machines Corporation, Armonk, NY, USA) was used for statistical analysis. The sample size was estimated based on the complication rate of 45% from a multicentre INTUBE study.[6] We assumed a 30% relative reduction in the complication rate to 31.5% after the bundle implementation, as we believed this would be a significant reduction comparable to the study by Jaber et al.[4] With a 5% alpha error and 80% power, the sample size was calculated as 202 in each phase.
The Shapiro–Wilk test was used to assess the normality of the distribution, and the test results indicated that the distribution was non-normal for continuous variables. Summary statistics were calculated using proportions for categorical and binary variables, and median and interquartile range (IQR) were used for variables following a non-parametric distribution. The Mann-Whitney U test was employed for continuous variables (age, SOFA, APACHE II, and CCI). Analysis of categorical variables was performed using the Chi-square test of association (gender, type of admission, indication for intubation, intubation urgency, presence of two intubators, Cormack-Lehane (CL) grade, use of capnography, critical HI, severe hypoxia, 28-day mortality, oral injury, oesophageal intubation, gastric aspiration). P values < 0.05 were considered statistically significant.
RESULTS
We compared intubation practices and complications in 404 patients, with 202 patients in each of the Phase I and Phase II groups. The baseline demographic characteristics were comparable between the two phases [Table 2]. The majority of patients were male, and the CCI and APACHE II scores were similar in both phases. The median (IQR) SOFA score in Phase II was 9 (6–11), compared to 8 (6–10) in Phase I, suggesting that Phase II likely had slightly more critically ill patients.
Table 2.
Demographics and general characteristics
| Parameters | Phase I | Phase II | P |
|---|---|---|---|
| Age (years) | 56 (46–68) | 60 (46–69) | 0.149 |
| Gender | 0.449 | ||
| Male (%) | 144 (71) | 137 (68) | |
| Female (%) | 58 (29) | 65 (32) | |
| SOFA score | 8 (6–10) | 9 (6–11) | 0.029 |
| APACHE II score | 20 (16–24) | 19 (14–22) | 0.196 |
| Charlson Comorbidity Index | 3 (1–5) | 3 (1–5) | 0.526 |
| Type of admission | 0.674 | ||
| Medical | 189 (94) | 191 (95) | |
| Surgical | 13 (6) | 11 (5) |
Data expressed as number (percentage) or median (interquartile range). APACHE 2=Acute Physiology and Chronic Health Evaluation 2 score; SOFA=Sequential Organ Failure Assessment
The pre-intubation characteristics in the two groups are listed in Table 3. The urgency of intubation was comparable in the two groups, and the primary indications for intubation were airway protection. The airway evaluation practice using the MACOCHA score assessment significantly improved in Phase II after the educational training (96% vs 72%, P < 0.001). A detailed description of intubation characteristics and conditions is presented in Table 4. The incidence of first-pass intubation improved from 77% in Phase I to 85% in Phase II, although it was not statistically significant (P = 0.069). Similarly, the difficulty of intubation, as per the CL grading, was reduced (9% vs 2%, P < 0.001). The use of capnography to confirm the endotracheal tube position increased significantly. In the usage of drugs, fentanyl was the most used for analgesia and sedation, and rocuronium was the most used muscle relaxant in both phases.
Table 3.
Pre-intubation characteristics and conditions
| Parameters | Phase I | Phase II | P | |
|---|---|---|---|---|
| Intubation urgency n (%) | Immediate | 31 (15) | 41 (20) | 0.302 |
| Relative emergency (<1 h) | 123 (61) | 109 (54) | ||
| Deferred emergency (>1 h) | 48 (23) | 52 (26) | ||
| Indications for intubation n (%) | Airway protection | 76 (38) | 83 (41) | 0.153 |
| Type 1 Respiratory failure | 54 (27) | 41 (20) | ||
| Type 2 Respiratory failure | 17 (8) | 10 (5) | ||
| Increased work of breathing (metabolic/sepsis) | 55 (27) | 68 (34) | ||
| Airway evaluation done | Yes | 145 (72) | 193 (96) | <0.001 |
| No | 57 (28) | 9 (4) | ||
| MACOCHA Score n (%) | ≥3 | 85 (42) | 115 (57) | <0.001 |
| <3 | 60 (30) | 79 (39) | ||
| Not assessed | 57 (28) | 8 (4) | ||
| Patient position | Sniffing position | 133 (66) | 163 (80) | <0.001 |
| Ramp position | 19 (9) | 20 (10) | ||
| Not optimised | 50 (25) | 19 (10) | ||
| Pre-oxygenation n (%) | Self-inflating bag | 96 (48) | 88 (44) | 0.424 |
| NIV | 106 (52) | 114 (56) | ||
| Vasopressor requirement pre-intubation | No | 152 (75) | 143 (71) | 0.313 |
| Yes | 50 (25) | 59 (29) | ||
| Intubator experience | Junior resident | 121 (60) | 104 (51) | 0.182 |
| Senior resident | 69 (34) | 87 (43) | ||
| Consultant | 12 (6) | 11 (6) | ||
| Presence of two intubators | Yes | 138 (68) | 183 (90) | <0.001 |
| No | 64 (32) | 19 (10) | ||
Data expressed as number (percentage). NIV=non-invasive ventilation
Table 4.
Intubation characters, conditions and complications
| Parameters | Phase-I Incidence n (%) | Phase-II Incidence n (%) | P | |
|---|---|---|---|---|
| Number of attempts n (%) | 1 | 155 (77) | 172 (85) | 0.069 |
| 2 | 41 (20) | 28 (14) | ||
| 3 | 6 (3) | 2 (1) | ||
| Rapid sequence intubation n (%) | No | 13 (6) | 2 (1) | 0.2 |
| Yes | 189 (94) | 200 (100) | ||
| Sellick’s manoeuvre | Yes | 117 (58) | 200 (99) | <0.001 |
| No | 85 (42) | 2 (1) | ||
| Intubation difficulty Cormack-Lehane Grade n (%) | I | 59 (29) | 36 (18) | <0.001 |
| IIA | 94 (47) | 103 (51) | ||
| IIB | 32 (16) | 58 (29) | ||
| III | 16 (8) | 5 (2) | ||
| IV | 1 (1) | 0 (0) | ||
| Use of intubation adjuncts n (%) | Stylet | 169 (84) | 189 (93) | 0.007 |
| Bougie | 17 (8) | 6 (3) | ||
| None | 16 (8) | 7 (4) | ||
| Endotracheal intubation technique n (%) | Direct laryngoscopy | 194 (96) | 195 (97) | 0.606 |
| Video Laryngoscopy | 7 (3) | 7 (3) | ||
| FONA | 1 (1) | 0 (0) | ||
| Use of Capnography | Yes | 163 (81) | 198 (98) | <0.001 |
| No | 39 (19) | 4 (2) | ||
| Drugs used for sedation | Fentanyl | 199 (99) | 197 (97) | - |
| Midazolam | 76 (38) | 88 (44) | ||
| Propofol | 16 (8) | 6 (3) | ||
| Ketamine | 8 (5) | 5 (2) | ||
| Etomidate | 3 (2) | 4 (2) | - | |
| Drugs used for paralysis | Rocuronium | 190 (94) | 192 (95) | |
| Succinylcholine | 10 (5) | 9 (5) | ||
| Cis-atracurium | 2 (1) | 1 (1) | ||
| Major complications | Number of patients with major complications | 91 (45) | 59 (29) | <0.001 |
| Critical haemodynamic instability | 78 (39) | 38 (19) | <0.001 | |
| Severe hypoxia (SpO2 <80%) | 24 (12) | 18 (9) | 0.328 | |
| Cardiac arrest | 6 (3) | 2 (1) | 0.057 | |
| 28-day mortality | 107 (53) | 94 (46.5) | 0.196 | |
| Minor complications | Oral/dental injury | 17 (8) | 16 (8) | 0.606 |
| Oesophageal intubation | 12 (6) | 7 (3) | 0.169 | |
| Gastric aspiration | 9 (4) | 4 (2) | 0.159 | |
| Bradycardia | 8 (4) | 4 (2) | 0.241 | |
| Arrhythmias | 3 (2) | 4 (2) | 0.703 | |
| Pneumothorax | Nil | Nil | - | |
Data expressed as number (percentage). FONA=front-of-neck access
Severe hypotension was the main complication, followed by severe hypoxemia during both phases of the study [Table 4]. The number of patients with major complications decreased significantly after the introduction of the bundle (45% vs 29%, P < 0.001). Similarly, the overall incidence of major complications reduced in Phase II. The incidence of cardiac arrest was not significantly different during both phases of the study (3% vs 1%, P < 0.057). The incidence of minor complications occurring during ETI, including oral and dental injuries, oesophageal intubation, gastric aspiration, bradycardia, and arrhythmia, was comparable in the two groups [Table 4]. No incidences of pneumothorax were seen in either phase.
DISCUSSION
In our study, we identified critical HI as the major complication associated with ETI. Implementing the intubation bundle reduced the incidence of critical HI from 39% to 19%. Additionally, we found that implementing the bundle led to improvements in intubation practices, such as airway assessment by the MACOCHA score, optimisation of patient positioning, and the presence of two intubators. This practice change might be associated with a decrease in CL-graded difficult intubation and an increase in successful first-pass intubations.
Critical HI is the predominant complication in our study, which is consistent with other studies in ICU and emergency settings.[6,10,11,12] To reduce the incidence of complications during ETI, Jaber et al.,[4] in a landmark study, found that the use of a 10-point Montpellier intubation bundle in the peri-intubation period resulted in a reduction of severe haemodynamic collapse and other major complications. A modified Montpellier protocol, as described by Corl et al.[12] and Ghosh et al.,[13] was found to be associated with higher first-pass intubation rates and fewer complications in the ICU. Our intubation bundle is based on the Montpellier bundle, along with the Difficult Airway Society guidelines, as we felt the need for an airway management plan to be incorporated into the ETI bundle.[1,4,5]
A pre-existing low blood pressure (BP) was seen in one-fourth of patients during both phases. However, the occurrence of critical HI was comparatively lower in Phase II, as the intubation bundle emphasised BP optimisation using fluids and vasopressors pre-intubation. As part of the bundle, administering fluids or using vasopressors pre-emptively may mitigate the negative impact of sedatives and muscle relaxants used during the procedure. However, other studies have failed to demonstrate the benefit of preloading with crystalloids during intubation, suggesting that complex pathophysiological mechanisms may be at play in critically ill patients, which require further evaluation.[14,15,16]
The incidence of severe hypoxia in our study was 12% in Phase I and reduced to 9% in Phase II. In previous studies, the incidence of hypoxia has been reported to range from 10% to 27%.[17,18,19,20] The most common indications for intubation in our setting were for airway protection and septic shock, compared to acute respiratory failure as the reason for intubation in other studies. This may explain the relatively lower incidence of hypoxia in our study compared to different studies. In our study, the use of NIV exceeded 50%. Despite existing evidence on the use of NIV to prevent peri-intubation hypoxia, the implementation of the bundle did not alter its practice.[17] This was likely due to pre-existing practices and preferences among clinicians, as ETI for airway protection was more prevalent than for respiratory failure in our study population. In our study, bag-mask ventilation was the other commonly used technique for pre-oxygenation, and evidence suggests that bag-mask, NIV, and high-flow nasal oxygenation (HFNO) can abate severe hypoxia during ETI.[18,19,20,21] HFNO can also be used to provide apnoeic oxygenation during emergency intubation, and studies have shown this technique reduces the incidence of hypoxia during the peri-intubation period.[21,22]
We noted a decrease in the incidence of difficult intubations, specifically those of CL grades 3 and 4, after introducing the intubation bundle. This may be due to the increased use of airway assessment tools, such as MACOCHA. It is a validated score to predict a difficult airway and may help clinicians prepare for complex airway management in emergencies.[23] Many physicians in the ICU do not perform an airway assessment due to the urgency of the procedure. However, our study showed that this score can be easily used in ICU scenarios. Similarly, optimising patient position led to improved CL grading. This also helped improve first-pass intubations from 77% to 85%, although the difference was statistically insignificant. Junior residents of anaesthesia were posted in our ICU after 1 year of training, and we also had critical care senior residents working in our ICU. Hence, the intubators in our ICU had adequate airway training. The presence of two intubators improved after the bundle’s usage and may have also contributed to fewer complications.
Studies and guidelines have recommended the use of induction agents such as ketamine and etomidate for ETI in critically ill patients, as these drugs are associated with less cardiovascular instability.[1,5,24,25] Instead, in our study, we found that opioid-based fentanyl with midazolam was primarily used for sedation, suggesting that local practices vary and that there is a need for individual centre-based bundles. It is reported that the use of fentanyl with midazolam was associated with a lower incidence of complications during ETI, suggesting further studies in this regard and the updation of guidelines based on this evidence.[10] In addition, there are considerable differences in the practices of the Western and middle-income countries, which makes it challenging to generalise practices across the globe.
Our study had many limitations. It was a single-centre study; hence, it is difficult to generalise the study findings to the overall population. Although an intubation bundle was used in all intubations during the implementation phase, we did not record adherence to each component of the bundle. The use of video laryngoscopy was lower, even though we had a MACOCHA score of >3 in 57% of cases in Phase II. We did not use randomisation; hence, it is difficult to establish the causality of the bundle implementation in reducing complications.
CONCLUSION
Our study demonstrates that implementing a peri-intubation bundle in ICU settings makes ETI practices safer, as the bundle significantly decreases the incidence of life-threatening complications.
Conflicts of interest
There are no conflicts of interest.
Study data availability
De-identified data may be requested with reasonable justification from the authors (email to the corresponding author) and shall be shared after approval as per the authors’ institution’s policy.
Disclosure of use of artificial intelligence (AI)-assistive or generative tools
The AI tools or language models (LLM) have not been utilised in the manuscript, except that software has been used for grammar corrections and references.
Declaration of use of permitted tools
The scales/scores/figures/tables used/published in this study are freely available and not copyrighted.
Authors contributions
PJ and SSM: Concepts, Design, Definition of intellectual content, literature search, conduct of cases, data acquisition, manuscript preparation, editing, review and approval. SR: Concepts, Design, manuscript editing and review. SC: Design, Definition of intellectual content, literature search, data analysis, manuscript editing and review. SR: Concepts, Design, literature search, conduct of cases, data acquisition, data analyses, and manuscript review. DHC: Data analyses, manuscript preparation, editing, and review. VP: definition of intellectual content, data acquisition and manuscript review.
Supplementary material
This article has supplementary material and can be accessed at this link. Supplementary Material at http://links.lww.com/IJOA/A35.
Acknowledgements
We acknowledge the ICU healthcare workers for their cooperation during the study.
Funding Statement
Nil.
REFERENCES
- 1.Myatra S, Ahmed S, Kundra P, Garg R, Ramkumar V, Patwa A, et al. The All India Difficult Airway Association 2016 guidelines for tracheal intubation in the Intensive Care Unit. Indian J Anaesth. 2016;60:922–30. doi: 10.4103/0019-5049.195485. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Myatra SN, Dhawan I, D’Souza SA, Elakkumanan LB, Jain D, Natarajan P. Recent advances in airway management. Indian J Anaesth. 2023;67:48–55. doi: 10.4103/ija.ija_26_23. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Cook TM, Woodall N, Harper J, Benger J. Major complications of airway management in the UK: Results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: Intensive care and emergency departments. Br J Anaesth. 2011;106:632–42. doi: 10.1093/bja/aer059. [DOI] [PubMed] [Google Scholar]
- 4.Jaber S, Jung B, Corne P, Sebbane M, Muller L, Chanques G, et al. An intervention to decrease complications related to endotracheal intubation in the intensive care unit: A prospective, multiple-centre study. Intensive Care Med. 2010;36:248–55. doi: 10.1007/s00134-009-1717-8. [DOI] [PubMed] [Google Scholar]
- 5.Higgs A, McGrath BA, Goddard C, Rangasami J, Suntharalingam G, Gale R, et al. Guidelines for the management of tracheal intubation in critically ill adults. Br J Anaesth. 2018;120:323–52. doi: 10.1016/j.bja.2017.10.021. [DOI] [PubMed] [Google Scholar]
- 6.Russotto V, Myatra SN, Laffey JG, Tassistro E, Antolini L, Bauer P, et al. Intubation practices and adverse peri-intubation events in critically ill patients from 29 countries. JAMA. 2021;325:1164–72. doi: 10.1001/jama.2021.1727. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Knaus WA, Zimmerman JE, Wagner DP, Draper EA, Lawrence DE. APACHE-acute physiology and chronic health evaluation: a physiologically based classification system. Crit Care Med. 1981;9:591–7. doi: 10.1097/00003246-198108000-00008. [DOI] [PubMed] [Google Scholar]
- 8.Vincent JL, Moreno R, Takala J, Willatts S, De Mendonça A, Bruining H, et al. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996;22:707–10. doi: 10.1007/BF01709751. [DOI] [PubMed] [Google Scholar]
- 9.Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40:373–83. doi: 10.1016/0021-9681(87)90171-8. [DOI] [PubMed] [Google Scholar]
- 10.R NP, Chaudhari HK, Kulkarni AP, Dangi MS, Bhagat V, Siddiqui SS, et al. Compliance with intubation bundle and complications in critically ill patients: A need to revisit the bundle components! Trends Anaesth Crit Care. 2022;42:26–33. [Google Scholar]
- 11.Jafra A, Jain K, Sravani MV, Yaddanapudi LN, Kumar P. Tracheal intubation practices and adverse events in trauma victims on arrival to trauma triage: A single centre prospective observational study. Indian J Anaesth. 2022;66:180–6. doi: 10.4103/ija.ija_919_21. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.Corl KA, Dado C, Agarwal A, Azab N, Amass T, Marks SJ, et al. A modified Montpellier protocol for intubating intensive care unit patients is associated with an increase in first-pass intubation success and fewer complications. J Crit Care. 2018;44:191–5. doi: 10.1016/j.jcrc.2017.11.014. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.Arora G, Kumar N, Singh A, Ghosh S, Chawla A, Salhotra R, et al. Implementation of a revised montpellier bundle on the outcome of intubation in critically ill patients: A quality improvement project. Indian J Crit Care Med. 2022;26:1106–14. doi: 10.5005/jp-journals-10071-24332. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14.Janz DR, Casey JD, Semler MW, Russell DW, Dargin J, Vonderhaar DJ, et al. Effect of a fluid bolus on cardiovascular collapse among critically ill adults undergoing tracheal intubation (PrePARE): A randomised controlled trial. Lancet Respir Med. 2019;7:1039–47. doi: 10.1016/S2213-2600(19)30246-2. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.Russell DW, Casey JD, Gibbs KW, Ghamande S, Dargin JM, Vonderhaar DJ, et al. Effect of fluid bolus administration on cardiovascular collapse among critically ill patients undergoing tracheal intubation: A randomized clinical trial. JAMA. 2022;328:270–9. doi: 10.1001/jama.2022.9792. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 16.Russotto V, Myatra SN, Laffey JG. What’s new in airway management of the critically ill. Intensive Care Med. 2019;45:1615–8. doi: 10.1007/s00134-019-05757-0. [DOI] [PubMed] [Google Scholar]
- 17.Gibbs KW, Semler MW, Driver BE, Seitz KP, Stempek SB, Taylor C, et al. Noninvasive ventilation for preoxygenation during emergency intubation. N Engl J Med. 2024;390:2165–77. doi: 10.1056/NEJMoa2313680. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 18.Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, et al. Bag-mask ventilation during tracheal intubation of critically ill adults. N Engl J Med. 2019;380:811–21. doi: 10.1056/NEJMoa1812405. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19.Frat JP, Ricard JD, Quenot JP, Pichon N, Demoule A, Forel JM, et al. Non-invasive ventilation versus high-flow nasal cannula oxygen therapy with apnoeic oxygenation for preoxygenation before intubation of patients with acute hypoxaemic respiratory failure: A randomised, multicentre, open-label trial. Lancet Respir Med. 2019;7:303–12. doi: 10.1016/S2213-2600(19)30048-7. [DOI] [PubMed] [Google Scholar]
- 20.De Jong A, Myatra SN, Roca O, Jaber S. How to improve intubation in the intensive care unit. Update on knowledge and devices. Intensive Care Med. 2022;48:1287–98. doi: 10.1007/s00134-022-06849-0. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 21.Miguel-Montanes R, Hajage D, Messika J, Bertrand F, Gaudry S, Rafat C, et al. Use of high-flow nasal cannula oxygen therapy to prevent desaturation during tracheal intubation of intensive care patients with mild-to-moderate hypoxemia. Crit Care Med. 2015;43:574–83. doi: 10.1097/CCM.0000000000000743. [DOI] [PubMed] [Google Scholar]
- 22.Oliveira J E Silva L, Cabrera D, Barrionuevo P, Johnson RL, Erwin PJ, Murad MH, et al. Effectiveness of apneic oxygenation during intubation: A systematic review and meta-analysis. Ann Emerg Med. 2017;70:483–94. doi: 10.1016/j.annemergmed.2017.05.001. [DOI] [PubMed] [Google Scholar]
- 23.De Jong A, Molinari N, Terzi N, Mongardon N, Arnal JM, Guitton C, et al. Early Identification of patients at risk for difficult intubation in the intensive care unit: Development and validation of the MACOCHA score in a multicenter cohort study. Am J Respir Crit Care Med. 2013;187:832–9. doi: 10.1164/rccm.201210-1851OC. [DOI] [PubMed] [Google Scholar]
- 24.Matchett G, Gasanova I, Riccio CA, Nasir D, Sunna MC, Bravenec BJ, et al. Etomidate versus ketamine for emergency endotracheal intubation: A randomized clinical trial. Intensive Care Med. 2022;48:78–91. doi: 10.1007/s00134-021-06577-x. [DOI] [PubMed] [Google Scholar]
- 25.Sharda SC, Bhatia MS. Etomidate compared to ketamine for induction during rapid sequence intubation: A systematic review and meta-analysis. Indian J Crit Care Med. 2022;26:108–13. doi: 10.5005/jp-journals-10071-24086. [DOI] [PMC free article] [PubMed] [Google Scholar]