Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure

Not Applicable

Completed

• Conditions: Noninvasive Ventilation
• Interventions: Procedure: Different level of PEEP

• Registration Number: NCT05193786
• Lead Sponsor: Chongqing Medical University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-12-20
• Study Start: 2022-01-11
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-18
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High PEEP group	Different level of PEEP	In high PEEP group, the PEEP was 10-15 cmH2O and inspiratory pressure was 15-20 cmH2O in noninvasive ventilation.
Low PEEP group	Different level of PEEP	In low PEEP group, the PEEP was 5 cmH2O and inspiratory pressure was 10-20 cmH2O in noninvasive ventilation.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China