Using higher PEEP with mask noninvasive ventilation for people 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
NA · Chongqing Medical University · NCT07298889
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 706 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chongqing Medical University (other) |
| Locations | 1 site (Chongqing) |
| Trial ID | NCT07298889 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chongqing
- The First Affiliated Hospital of Chongqing Medical University — Chongqing, China (RECRUITING)
Study contacts
- Study coordinator: Mengyi Ma
- Email: 1062914316@qq.com
- Phone: 86-023-89012680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Noninvasive Ventilation, Pneumonia, ARDS