Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure

N/ACompletedNCT05193786

Chongqing Medical University380 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

380

Conditions

Noninvasive Ventilation

Interventions

Different level of PEEPPROCEDURE

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

Eligibility

Sex: ALLMin age: 16 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Outcomes

Primary Outcomes

Rate of noninvasive ventilation failure

Noninvasive ventilation failure was defined as intubation, death or withdrawal of therapy during noninvasive ventilation.

Time frame: From randomization to 28 days of study

Secondary Outcomes

28-day mortality

Died within 28 days of study

Time frame: From randomization to 28 days of study

Duration of noninvasive ventilation

The days spent on noninvasive ventilation

Time frame: From beginning to 28 days of study

Duration of invasive mechanical ventilation

The days spent on invasive ventilation

Time frame: From randomization to 28 days of study

Length of stay in ICU

The days spent in ICU

Time frame: From beginning to 28 days of study

Length of stay in hospital

The days spent in hospital

Time frame: From beginning to 28 days of study

The changes of PaO2/FiO2

Oxygenation was calculated as PaO2/FiO2.

Time frame: From randomization to 28 days of study

Side effect

Side effect included the incidence of pressure ulcer, pneumothorax, vomitting, aspiration and dryness

Time frame: From randomization to 28 days of study

Data from ClinicalTrials.gov

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