High PEEP in Noninvasive Ventilation Patients 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

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; ARDS; Noninvasive Ventilation
• Intervention / Treatment: Procedure: The level of PEEP during noninvasive ventilation

• Study Type: Interventional
• Enrollment (Estimated): 706
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mengyi Ma; Phone Number: 86-023-89012680; Email: 1062914316@qq.com

Study Locations

• China
  • Chongqing, China
    • Recruiting
    • The First Affiliated Hospital of Chongqing Medical University
    • Contact: Jun Duan; Phone Number: 86-023-89012680; Email: duanjun412589@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High PEEP group; Patients in high PEEP group will received 10 to 15 cmH2O of PEEP during noninvasive ventilation.	Procedure: 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.
Active Comparator: Low PEEP group; Patients in low PEEP group will received 5 cmH2O of PEEP during noninvasive ventilation.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
28-day intubation-free survival	from randomization to 28 days after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU mortality		up to 24 weeks
Hospital mortality		up to 24 weeks
28-day intubation rate		from randomization to 28 days after randomization
the need for intubation within 28 days	The rate of the need for intubation within 28 days after randomization was assessed by two independent reviewers with extensive critical care experience.	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	The 7-category ordinal scale is as follows: 1 = not hospitalized and has resumed normal activities; 2 = not hospitalized but unable to resume normal activities; 3 = hospitalized without requiring supplemental oxygen; 4 = hospitalized and requiring supplemental oxygen; 5 = hospitalized and requiring HFNC, NIV, or both; 6 = hospitalized and requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; 7 = death.	from randomization to 28 days after randomization
28-day invasive ventilator-free days		from randomization to 28 days after randomization
Length of ICU stay		up to 24 weeks
Length of hospital stay		up to 24 weeks
60-day mortality		from randomization to 60 days after randomization
28-day noninvasive ventilator days		from randomization to 28 days after randomization

Collaborators and Investigators

• Sponsor: Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 20, 2025
• First Posted (Estimated): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: ChongqingMU06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: These study data contain ethnic demographic information. Since it remains unclear whether Chinese laws permit the public disclosure of such data upon the completion of the research, a decision has been made to temporarily withhold data sharing during the study design phase.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No