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NCT Number: NCT07298889

High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS

Noninvasive ventilation is commonly employed in patients with pneumonia or acute respiratory distress syndrome (ARDS) and has been shown to reduce the need for intubation and invasive mechanical ventilation. However, the rate of noninvasive ventilation failure remains substantial, at approximately 40%. Compared with patients in whom noninvasive ventilation succeeds, those who experience noninvasive ventilation failure have a higher likelihood of mortality during their intensive care unit or hospital stay. Therefore, improving the success rate of noninvasive ventilation is clinically important. In patients with lung consolidation receiving invasive mechanical ventilation, high positive end-expiratory pressure (PEEP) can improve oxygenation. Noninvasive ventilation operates on similar physiological principles and can also deliver high PEEP via a mask interface. Nevertheless, there is limited evidence regarding the use of high PEEP during mask-delivered noninvasive ventilation. This study aimed to evaluate whether high PEEP can increase intubation-free survival in patients with pneumonia or ARDS who are treated with noninvasive ventilation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >18 years
  • PaO2/FiO2 ≤300 mmHg or SpO2/FiO2 ≤315(SpO2 ≤97%)
  • Anticipated NIV duration > 12 h
  • Preserved consciousness (GCS≥13)

Exclusion criteria

  • Use of NIV > 24 h before randomization
  • Acute-on-chronic respiratory failure
  • Congestive heart failure
  • Use of NIV after extubation (within 48 hours)
  • Contraindications to NIV (e.g., anatomical malformations, recent pulmonary/esophageal surgery [within 7 days])
  • Pneumothorax
  • NIV intolerance
  • Refusal to participate
  • Pregnancy
  • Need for emergency intubation

Treatment and study plan

The level of PEEP during noninvasive ventilation

Procedure

In patients receiving noninvasive ventilation, participants will be randomly assigned to either a low or a high PEEP group. In the high PEEP group, PEEP will be set between 10 and 15 cmH2O. In the low PEEP group, PEEP will be maintained at 5 cmH2O.

Primary outcomes

  1. 28-day intubation-free survival

    Time frame: from randomization to 28 days after randomization

Secondary outcomes

  1. 28-day intubation rate

    Time frame: from randomization to 28 days after randomization

  2. the need for intubation within 28 days

    Time frame: from randomization to 28 days after randomization

    The rate of the need for intubation within 28 days after randomization was assessed by two independent reviewers with extensive critical care experience.

  3. 28-day survival

    Time frame: from randomization to 28 days after randomization

  4. 7-category ordinal scale for clinical improvement at 28 days

    Time frame: from randomization to 28 days after randomization

    The 7-category ordinal scale is as follows: 1 = not hospitalized and has resumed normal activities; 2 = not hospitalized but unable to resume normal activities; 3 = hospitalized without requiring supplemental oxygen; 4 = hospitalized and requiring supplemental oxygen; 5 = hospitalized and requiring HFNC, NIV, or both; 6 = hospitalized and requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; 7 = death.

  5. 28-day invasive ventilator-free days

    Time frame: from randomization to 28 days after randomization

  6. 28-day noninvasive ventilator days

    Time frame: from randomization to 28 days after randomization

  7. Length of ICU stay

    Time frame: up to 24 weeks

  8. Length of hospital stay

    Time frame: up to 24 weeks

  9. ICU mortality

    Time frame: up to 24 weeks

  10. Hospital mortality

    Time frame: up to 24 weeks

  11. 60-day mortality

    Time frame: from randomization to 60 days after randomization

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study title

Effect of High Versus Low Positive End-Expiratory Pressure on Intubation-Free Survival in Patients With Pneumonia or ARDS Receiving Noninvasive Ventilation: A Multicenter Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 23, 2025
Registry last updated
Jan 7, 2026

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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