High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS

NCT07298889 | Recruiting DMC

• 1 other identifier: ChongqingMU06
• Study Type: interventional
• Target: 706
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Noninvasive Ventilation; Pneumonia; ARDS

Outcome Measures

Primary Outcomes (1)

• 28-day intubation-free survival

  from randomization to 28 days after randomization

Secondary Outcomes (11)

• 28-day intubation rate

  from randomization to 28 days after randomization

• the need for intubation within 28 days

  from randomization to 28 days after randomization

• 28-day survival

  from randomization to 28 days after randomization

• 7-category ordinal scale for clinical improvement at 28 days

  from randomization to 28 days after randomization

• 28-day invasive ventilator-free days

  from randomization to 28 days after randomization

Study Arms (2)

High PEEP group

EXPERIMENTAL

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

Procedure: The level of PEEP during noninvasive ventilation

Low PEEP group

ACTIVE COMPARATOR

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

Procedure: The level of PEEP during noninvasive ventilation

Interventions

The level of PEEP during noninvasive ventilation PROCEDURE

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.

High PEEP group; Low PEEP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Mengyi Ma

CONTACT

86-023-89012680; 1062914316@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 23, 2025
• Study Start: January 4, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)