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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
706
In 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.
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
RECRUITING28-day intubation-free survival
Time frame: from randomization to 28 days after randomization
28-day intubation rate
Time frame: from randomization to 28 days after randomization
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.
Time frame: from randomization to 28 days after randomization
28-day survival
Time frame: from randomization to 28 days after randomization
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.
Time frame: from randomization to 28 days after randomization
28-day invasive ventilator-free days
Time frame: from randomization to 28 days after randomization
28-day noninvasive ventilator days
Time frame: from randomization to 28 days after randomization
Length of ICU stay
Time frame: up to 24 weeks
Length of hospital stay
Time frame: up to 24 weeks
ICU mortality
Time frame: up to 24 weeks
Hospital mortality
Time frame: up to 24 weeks
60-day mortality
Time frame: from randomization to 60 days after randomization
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