High PEEP during noninvasive ventilation for hypoxemic respiratory failure
A Physiological Study of High PEEP During Noninvasive Ventilation in Patients With Hypoxemic Respiratory Failure
This project will test whether higher PEEP settings on noninvasive ventilators help adults with hypoxemic respiratory failure improve oxygen levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT07503509 on ClinicalTrials.gov |
What this trial studies
This interventional protocol applies higher positive end-expiratory pressure (PEEP) during noninvasive ventilation in adults with hypoxemic respiratory failure and records physiological responses. Eligible participants have PaO2/FiO2 ≤ 300 and PaCO2 ≤ 50 mmHg and must be managed on a noninvasive ventilator capable of esophageal pressure monitoring. The team will adjust PEEP levels while measuring esophageal pressures and gas exchange to clarify mechanisms by which high PEEP may improve oxygenation. The single-center trial is conducted at The First Affiliated Hospital of Chongqing Medical University and excludes patients with heart-failure‑driven respiratory failure, asthma, acute COPD exacerbation, or pneumothorax.
Who should consider this trial
Good fit: Adults (≥18) with hypoxemic respiratory failure (PaO2/FiO2 ≤ 300 and PaCO2 ≤ 50 mmHg) who are receiving noninvasive ventilation on a device that supports esophageal pressure monitoring and who do not have heart-failure‑driven respiratory failure, asthma, acute COPD exacerbation, or pneumothorax.
Not a fit: Patients whose respiratory failure is primarily due to heart failure, asthma, or acute COPD exacerbation, those with pneumothorax, or those unable or unwilling to undergo noninvasive ventilation with esophageal pressure monitoring are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could identify NIV PEEP settings that improve oxygenation and potentially reduce the need for intubation in hypoxemic respiratory failure.
How similar studies have performed: Higher PEEP has improved oxygenation in invasively ventilated ARDS patients, but the physiological effects of high PEEP during noninvasive ventilation are less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. PaCO₂ ≤ 50 mmHg 3. PaO₂/FiO₂ ≤ 300 mmHg 4. Use of a noninvasive ventilator with esophageal pressure monitoring capability (e.g., Mindray SV70) - Exclusion Criteria: 1. Respiratory failure caused by heart failure, asthma, or acute exacerbation of chronic obstructive pulmonary disease (COPD) (COPD as a comorbidity may be included) 2. Pneumothorax 3. Patients who refuse to participate in this trial -
Where this trial is running
Chongqing, Chongqing Municipality
- The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jun Duan, MD — First Affiliated Hospital of Chongqing Medical University
- Study coordinator: Jun Duan
- Email: duanjun412589@163.com
- Phone: +86-89012680
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.