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Recruiting Not applicable

High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS

NCT07298889 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-01-04
Last updated
2026-01-07

Condition(s) studied

Noninvasive VentilationPneumoniaARDS

Investigational drug(s) / intervention(s)

The level of PEEP during noninvasive ventilation

The 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 28-day intubation-free survival — from randomization to 28 days after randomization

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Chongqing Medical University Chongqing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07298889 on ClinicalTrials.gov ↗ ← All trials in China