Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure

Noninvasive Ventilation Clinical Trial

Official title:

Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05193786
• Other study ID #: ChongqingMU5
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2023
• Source: Chongqing Medical University
• Contact: Jun Duan, Dr.
• Phone: +8615023077940
• Email: duanjun412589[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 348
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Noninvasive Ventilation
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

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