Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure

NCT05193786 | Completed

• 1 other identifier: ChongqingMU5
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Noninvasive Ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 28-day mortality

  From randomization to 28 days of study

• Duration of noninvasive ventilation

  From beginning to 28 days of study

• Duration of invasive mechanical ventilation

  From randomization to 28 days of study

• Length of stay in ICU

  From beginning to 28 days of study

• Length of stay in hospital

  From beginning to 28 days of study

Study Arms (2)

Low PEEP group

ACTIVE COMPARATOR

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

Procedure: Different level of PEEP

High PEEP group

EXPERIMENTAL

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

Interventions

Different level of PEEP PROCEDURE

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

High PEEP group; Low PEEP group

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

Study Officials

• Jun Duan, Dr.

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Model Details: Low versus high PEEP

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 18, 2022
• Study Start: January 11, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)