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Completed

NCT Number: NCT05193786

Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure

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

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Key information

Age range

16 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Different level of PEEP

Procedure

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

Primary outcomes

  1. Rate of noninvasive ventilation failure

    Time frame: From randomization to 28 days of study

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

Secondary outcomes

  1. 28-day mortality

    Time frame: From randomization to 28 days of study

    Died within 28 days of study

  2. Duration of noninvasive ventilation

    Time frame: From beginning to 28 days of study

    The days spent on noninvasive ventilation

  3. Duration of invasive mechanical ventilation

    Time frame: From randomization to 28 days of study

    The days spent on invasive ventilation

  4. Length of stay in ICU

    Time frame: From beginning to 28 days of study

    The days spent in ICU

  5. Length of stay in hospital

    Time frame: From beginning to 28 days of study

    The days spent in hospital

  6. The changes of PaO2/FiO2

    Time frame: From randomization to 28 days of study

    Oxygenation was calculated as PaO2/FiO2.

  7. Side effect

    Time frame: From randomization to 28 days of study

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

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2022
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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