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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>18 years

• PaO2/FiO2 ≤300 mmHg or SpO2/FiO2 ≤315(SpO2 ≤97%)

• Anticipated NIV duration \> 12 h

• Preserved consciousness (GCS≥13)

Locations
Other Locations
China
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Contact Information
Primary
Mengyi Ma
1062914316@qq.com
86-023-89012680
Time Frame
Start Date: 2026-01-04
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 706
Treatments
Experimental: High PEEP group
Patients in high PEEP group will received 10 to 15 cmH2O of PEEP during noninvasive ventilation.
Active_comparator: Low PEEP group
Patients in low PEEP group will received 5 cmH2O of PEEP during noninvasive ventilation.
Sponsors
Leads: Chongqing Medical University

This content was sourced from clinicaltrials.gov