Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using higher PEEP with mask noninvasive ventilation for people with pneumonia or ARDS

Official title: 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

Run by Chongqing Medical University · NCT07298889 · Data updated 2026-11-12

This trial will test whether giving higher PEEP through a mask during noninvasive ventilation helps adults with pneumonia or ARDS avoid intubation and improve oxygenation.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment706 (estimated)
SponsorChongqing Medical University
Academic / other
Locations1 site (Chongqing)
StatusRecruiting
StartedJanuary 4, 2026
Main results expectedDecember 31, 2029
Study endsDecember 31, 2029
Registry record updatedJanuary 7, 2026
Trial IDNCT07298889 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults over 18 with PaO2/FiO2 ≤300 mmHg or SpO2/FiO2 ≤315, expected to need NIV for more than 12 hours, and with preserved consciousness (GCS ≥13) are the intended participants.

Probably not a fit

Patients with acute-on-chronic respiratory failure, congestive heart failure, pneumothorax, recent thoracic/esophageal surgery, NIV after recent extubation, pregnancy, or those needing emergency intubation are excluded and unlikely to benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial compares different levels of positive end-expiratory pressure (PEEP) delivered via mask during noninvasive ventilation for adults with pneumonia or ARDS. Participants meeting oxygenation and consciousness criteria and expected to need NIV for more than 12 hours will receive NIV with specified PEEP settings. The study will track outcomes such as NIV failure, need for intubation, oxygenation measures, and clinical course in the ICU or hospital. The aim is to determine whether higher PEEP improves respiratory status and reduces the rate of progression to invasive mechanical ventilation.

Why it matters

Potential benefit: If successful, higher mask-delivered PEEP could lower the rate of noninvasive ventilation failure and reduce the need for intubation in these patients.

How similar studies have gone: High PEEP has improved oxygenation in invasively ventilated patients with lung consolidation, but evidence for applying high PEEP during mask noninvasive ventilation is limited and not well established.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

* 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

Where it's running

  • The First Affiliated Hospital of Chongqing Medical University
    Chongqing, China
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.