Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure

Chongqing Medical University

Status: Completed

Conditions: Noninvasive Ventilation

Treatments: Procedure: Different level of PEEP

Study type: Interventional

Funder types: Other

Identifiers

NCT05193786

ChongqingMU5

Details and patient eligibility

About

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

Full 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.

Enrollment: 380 patients

Sex: All

Ages: 16 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 2 patient groups

Low PEEP group

Active Comparator group

Description:

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

Treatment:

Procedure: Different level of PEEP

High PEEP group

Experimental group

Description:

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

Treatment:

Procedure: Different level of PEEP