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Recruiting NCT07298889

High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS

No phase Interventional Noninvasive Ventilation Pneumonia ARDS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The level of PEEP during noninvasive ventilation.
Who it may be relevant to
Registry conditions: Noninvasive Ventilation, Pneumonia, ARDS. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • Procedure The level of PEEP during noninvasive ventilation
    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 outcome measures

  • 28-day intubation-free survival [Time frame: from randomization to 28 days after randomization]
Secondary outcome measures (11)
  • 28-day intubation rate [Time frame: from randomization to 28 days after randomization]
  • the need for intubation within 28 days [Time frame: from randomization to 28 days after randomization]
  • 28-day survival [Time frame: from randomization to 28 days after randomization]
  • 7-category ordinal scale for clinical improvement at 28 days [Time frame: from randomization to 28 days after randomization]
  • 28-day invasive ventilator-free days [Time frame: from randomization to 28 days after randomization]
  • 28-day noninvasive ventilator days [Time frame: from randomization to 28 days after randomization]
  • Length of ICU stay [Time frame: up to 24 weeks]
  • Length of hospital stay [Time frame: up to 24 weeks]
  • ICU mortality [Time frame: up to 24 weeks]
  • Hospital mortality [Time frame: up to 24 weeks]
  • 60-day mortality [Time frame: from randomization to 60 days after randomization]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing

Identifiers

NCT: NCT07298889 · ChongqingMU06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗