Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure

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

Detailed Description
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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.

Official Title
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Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure

Conditions
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Noninvasive Ventilation

Intervention / Treatment
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* Procedure: Different level of PEEP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Low versus high PEEP
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low PEEP group<br>In low PEEP group, the PEEP was 5 cmH2O and inspiratory pressure was 10-20 cmH2O in noninvasive ventilation. | Procedure: Different level of PEEP<br>* Different level of PEEP (low versus high) was applied in noninvasive ventilation.<br>|
| Experimental: High PEEP group<br>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<br>* Different level of PEEP (low versus high) was applied in noninvasive ventilation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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