The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Location status: Recruiting
NCT Number: NCT07298889
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Chongqing, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: from randomization to 28 days after randomization
Time frame: from randomization to 28 days after randomization
Time frame: from randomization to 28 days after randomization
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
Time frame: from randomization to 28 days after randomization
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
Time frame: from randomization to 28 days after randomization
Time frame: up to 24 weeks
Time frame: up to 24 weeks
Time frame: up to 24 weeks
Time frame: up to 24 weeks
Time frame: from randomization to 60 days after randomization
Contact information is provided by the study sponsor or research team.
Chongqing Medical University
Other
Effect of High Versus Low Positive End-Expiratory Pressure on Intubation-Free Survival in Patients With Pneumonia or ARDS Receiving Noninvasive Ventilation: A Multicenter Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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