Zochios 2018.
Study characteristics | ||
Methods | RCT, parallel‐group design. Single‐centre study | |
Participants |
Total number of randomized participants: 100 Setting: ICU; UK Inclusion criteria: scheduled for CABG; > 18 years of age; ≥ 1 patient‐related risk factor for postoperative pulmonary complications; capable of performing 6MWT Exclusion criteria: contraindications to HFNC; needing CPAP preoperatively; did not meet criteria for extubation by 10 a.m. the day after surgery Baseline characteristics: Intervention group (HFNC):
Control group (NIV):
|
|
Interventions | Intervention group:
Control group:
|
|
Outcomes | Hospital length of stay; ICU length of stay; ICU re‐admission rate; in‐hospital mortality; escalation of respiratory support (unplanned CPAP, NIV or MV); pulmonary function tests; 6MWT; postoperative quality of recovery | |
Notes |
Funding/declarations of interest: funded by AAGBI. Fisher and Paykel Healthcare Ltd provided equipment and were not involved in data collection, analysis, and writing the manuscript. One author has received educational funding, honoraria or travel assistance from CSL Behring, Massimo, Pharmacosmos, Fisher and Paykel, Brightwake Ltd and Vifor Pharma. No other declarations or competing interests declared Study dates: not specified |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization |
Allocation concealment (selection bias) | Low risk | Use of a centralised online system |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding was not possible. Although we expected that this would not influence outcome data, we could not be certain of this. |
Blinding of outcome assessors (objective outcomes) | Low risk | Blinding of outcome assessors was not described; we did not anticipate that this would influence the assessment of objective outcome measures. |
Blinding of outcome assessors (subjective measures) | Low risk | Staff responsible for decisions regarding patient care were blinded to groups. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Few losses |
Selective reporting (reporting bias) | High risk | Study was prospectively registered with a clinical trials register (NCT02496923). We noted that mortality was an additional outcome that was not listed in the clinical trials register. All other outcomes were reported as described in the register. |
Other bias | Low risk | We identified no other sources of bias. |
AAGBI: Association of Anaesthetists of Great Britain and Ireland. AHRF: acute hypoxaemic respiratory failure AIDS: acquired immune deficiency syndrome APACHE II: acute physiology and chronic health evaluation II ASA: American Society of Anesthesiologists BiPAP: bilevel positive airway pressure BMI: body mass index CABG: coronary artery bypass graft CI: confidence interval COPD: chronic obstructive pulmonary disease CPAP: continuous positive airway pressure ECG: electrocardiographic EIT: electrical impedance tomography FiO2: fraction of inspired oxygen GCS: Glasgow coma score HFFM: high‐flow face mask HFNC: high‐flow nasal cannulae HFNO: high‐flow nasal oxygen ICU: intensive care unit IQR: interquartile range ITT: intention‐to‐treat MAP: mean arterial pressure M/F: male/female MV: mechanical ventilation n: number of participants NC: nasal cannula(e) NIPPV: non‐invasive positive‐pressure ventilation NIV: non‐invasive ventilation NIH: National Institutes of Health NRS: numerical rating scale PaCO2: carbon dioxide clearance PaO2: partial pressure of arterial oxygen PEEP: positive end‐expiratory pressure pH: potential of hydrogen SaO2: oxygen saturation of arterial blood SAPS II: simplified acute physiological score SBP: systolic blood pressure SBT: spontaneous breathing trial SD: standard deviation SOFA: sequential organ failure assessment score SpO2: oxygen saturation VAS: visual analogue scale VPAP: this is the name of a device 6MWT: six minute walk test