Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure

NCT ID: NCT05193786

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2024-08-31

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.

Conditions

Noninvasive Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low PEEP group

In low PEEP group, the PEEP was 5 cmH2O and inspiratory pressure was 10-20 cmH2O in noninvasive ventilation.

Group Type: ACTIVE_COMPARATOR

Different level of PEEP

Intervention Type: PROCEDURE

Different level of PEEP (low versus high) was applied in noninvasive ventilation.

High PEEP group

In high PEEP group, the PEEP was 10-15 cmH2O and inspiratory pressure was 15-20 cmH2O in noninvasive ventilation.

Group Type: EXPERIMENTAL

Different level of PEEP

Intervention Type: PROCEDURE

Different level of PEEP (low versus high) was applied in noninvasive ventilation.

Interventions

Different level of PEEP

Different level of PEEP (low versus high) was applied in noninvasive ventilation.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Duan jun

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Duan, Dr.

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Chongqing Medical University

Locations

The First Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Countries

China

Other Identifiers

ChongqingMU5

Identifier Type: -

Identifier Source: org_study_id