High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS

Chongqing Medical University

Status: Enrolling

Conditions: Noninvasive Ventilation; Pneumonia; ARDS

Treatments: Procedure: The level of PEEP during noninvasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT07298889

ChongqingMU06

Details and patient eligibility

About

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.

Enrollment: 706 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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706 participants in 2 patient groups

High PEEP group

Experimental group

Description:

Patients in high PEEP group will received 10 to 15 cmH2O of PEEP during noninvasive ventilation.

Treatment:

Procedure: The level of PEEP during noninvasive ventilation

Low PEEP group

Active Comparator group

Description:

Patients in low PEEP group will received 5 cmH2O of PEEP during noninvasive ventilation.

Treatment:

Procedure: The level of PEEP during noninvasive ventilation