About this trial
Noninvasive ventilation is commonly employed in patients with pneumonia or acute respiratory distress syndrome (ARDS) and has been shown to reduce the need for intubation and invasive mechanical ventilation. However, the rate of noninvasive ventilation failure remains substantial, at approximately 40%. Compared with patients in whom noninvasive ventilation succeeds, those who experience noninvasive ventilation failure have a higher likelihood of mortality during their intensive care unit or hospital stay. Therefore, improving the success rate of noninvasive ventilation is clinically important. In patients with lung consolidation receiving invasive mechanical ventilation, high positive end-expiratory pressure (PEEP) can improve oxygenation. Noninvasive ventilation operates on similar physiological principles and can also deliver high PEEP via a mask interface. Nevertheless, there is limited evidence regarding the use of high PEEP during mask-delivered noninvasive ventilation. This study aimed to evaluate whether high PEEP can increase intubation-free survival in patients with pneumonia or ARDS who are treated with noninvasive ventilation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years
PaO2/FiO2 ≤300 mmHg or SpO2/FiO2 ≤315(SpO2 ≤97%)
Anticipated NIV duration > 12 h
Preserved consciousness (GCS≥13)
Disqualifiers
Use of NIV > 24 h before randomization
Acute-on-chronic respiratory failure
Congestive heart failure
Use of NIV after extubation (within 48 hours)
Trial design
Parallel
Treatments tested in this trial
The level of PEEP during noninvasive ventilation
Procedure/SurgeryIn patients receiving noninvasive ventilation, participants will be randomly assigned to either a low or a high PEEP group. In the high PEEP group, PEEP will be set between 10 and 15 cmH2O. In the low PEEP group, PEEP will be maintained at 5 cmH2O.
Treatment groups
Trial outcomes
Primary outcomes
28-day intubation-free survival
Secondary outcomes
28-day intubation rate
the need for intubation within 28 days
The rate of the need for intubation within 28 days after randomization was assessed by two independent reviewers with extensive critical care experience.
28-day survival
7-category ordinal scale for clinical improvement at 28 days
The 7-category ordinal scale is as follows: 1 = not hospitalized and has resumed normal activities; 2 = not hospitalized but unable to resume normal activities; 3 = hospitalized without requiring supplemental oxygen; 4 = hospitalized and requiring supplemental oxygen; 5 = hospitalized and requiring HFNC, NIV, or both; 6 = hospitalized and requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; 7 = death.
Sponsors and contacts
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Chongqing Medical University
Lead sponsor
First Affiliated Hospital of Chongqing Medical University
Sponsor institution