High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS

Sponsor
Chongqing Medical University
Study ID
NCT07298889
Status
Recruiting
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Conditions

  • ARDS
  • Noninvasive Ventilation
  • Pneumonia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • The level of PEEP during noninvasive ventilation — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Dec 23, 2025
Start date
Jan 4, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
706 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

28-day intubation-free survival [ Time Frame: from randomization to 28 days after randomization ]

Central Contacts

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