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Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure

Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05193786
Enrollment
380
Registered
2022-01-18
Start date
2022-01-11
Completion date
2024-08-31
Last updated
2025-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Noninvasive Ventilation

Brief summary

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

Detailed 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.

Interventions

PROCEDUREDifferent level of PEEP

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

Sponsors

Chongqing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Low versus high PEEP

Eligibility

Sex/Gender
ALL
Age
16 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of noninvasive ventilation failureFrom randomization to 28 days of studyNoninvasive ventilation failure was defined as intubation, death or withdrawal of therapy during noninvasive ventilation.

Secondary

MeasureTime frameDescription
28-day mortalityFrom randomization to 28 days of studyDied within 28 days of study
Duration of noninvasive ventilationFrom beginning to 28 days of studyThe days spent on noninvasive ventilation
Duration of invasive mechanical ventilationFrom randomization to 28 days of studyThe days spent on invasive ventilation
Side effectFrom randomization to 28 days of studySide effect included the incidence of pressure ulcer, pneumothorax, vomitting, aspiration and dryness
Length of stay in hospitalFrom beginning to 28 days of studyThe days spent in hospital
The changes of PaO2/FiO2From randomization to 28 days of studyOxygenation was calculated as PaO2/FiO2.
Length of stay in ICUFrom beginning to 28 days of studyThe days spent in ICU

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026