Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure

Current study aimed to explore the effect of high PEEP during noninvasive ventilation among hypoxemic patients with acute respiratory failure.

Study Overview

• Status: Completed
• Conditions: Noninvasive Ventilation
• Intervention / Treatment: Procedure: Different level of PEEP

Detailed Description

This was a 1:1 randomized control trial to explore the effect of high versus low PEEP in noninvasive ventilation hypoxemic patients with acute respiratory failure. Several ICUs in China performed this study. In the high PEEP group, the PEEP maintained at 10-15 cmH2O, the inspiratory pressure maintained at 15-20 cmH2O. In the low PEEP group, the PEEP maintained at 5 cmH2O, the inspiratory pressure maintained at 10-20 cmH2O. The primary outcome was incidence of noninvasive ventilation failrue.

• Study Type: Interventional
• Enrollment (Actual): 380
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing, China
    • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• age between 16 and 85 years
• use of dedicated noninvasive ventilator
• PaCO2 ≤50 mmHg
• PaO2/FiO2 ≤300mmHg
• expectation of noninvasive ventilation >12 hours
• consciousness (Kelly score ≤3 or GCS≥13)

Exclusion Criteria

• use of noninvasive ventilation before randomization > 24 hours
• use of noninvasive ventilation due to heart failure, asthma, acute excerbation of COPD
• presence of contraindication of noninvasive ventilation such as malformation, rencent pulmonary or esophageal surgery et al.
• end stage disease (expectation of life < 6 months)
• pneumothorax
• noninvasive ventilation intolerance
• refusal of paticipation
• pregant woman
• requirement of 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
Active Comparator: Low PEEP group; In low PEEP group, the PEEP was 5 cmH2O and inspiratory pressure was 10-20 cmH2O in noninvasive ventilation.	Procedure: Different level of PEEP; Different level of PEEP (low versus high) was applied in noninvasive ventilation.
Experimental: High PEEP group; In high PEEP group, the PEEP was 10-15 cmH2O and inspiratory pressure was 15-20 cmH2O in noninvasive ventilation.	Procedure: Different level of PEEP; Different level of PEEP (low versus high) was applied in noninvasive ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of noninvasive ventilation failure	Noninvasive ventilation failure was defined as intubation, death or withdrawal of therapy during noninvasive ventilation.	From randomization to 28 days of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	Died within 28 days of study	From randomization to 28 days of study
Duration of noninvasive ventilation	The days spent on noninvasive ventilation	From beginning to 28 days of study
Duration of invasive mechanical ventilation	The days spent on invasive ventilation	From randomization to 28 days of study
Length of stay in ICU	The days spent in ICU	From beginning to 28 days of study
Length of stay in hospital	The days spent in hospital	From beginning to 28 days of study
The changes of PaO2/FiO2	Oxygenation was calculated as PaO2/FiO2.	From randomization to 28 days of study
Side effect	Side effect included the incidence of pressure ulcer, pneumothorax, vomitting, aspiration and dryness	From randomization to 28 days of study

Collaborators and Investigators

• Sponsor: Chongqing Medical University
• Investigators: Principal Investigator: Jun Duan, Dr., First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: ChongqingMU5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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