RecruitingNot ApplicableNCT07298889

High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS

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


Sponsor

Chongqing Medical University

Enrollment

706 participants

Start Date

Jan 4, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • Age \>18 years
  • PaO2/FiO2 ≤300 mmHg or SpO2/FiO2 ≤315(SpO2 ≤97%)
  • Anticipated NIV duration \> 12 h
  • Preserved consciousness (GCS≥13)

Exclusion Criteria10

  • Use of NIV \> 24 h before randomization
  • Acute-on-chronic respiratory failure
  • Congestive heart failure
  • Use of NIV after extubation (within 48 hours)
  • Contraindications to NIV (e.g., anatomical malformations, recent pulmonary/esophageal surgery \[within 7 days\])
  • Pneumothorax
  • NIV intolerance
  • Refusal to participate
  • Pregnancy
  • Need for emergency intubation

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREThe level of PEEP during noninvasive ventilation

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.


Locations(1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07298889


Related Trials