High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

706 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-04

Study Completion Date

2029-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Noninvasive Ventilation Pneumonia ARDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High PEEP group

Patients in high PEEP group will received 10 to 15 cmH2O of PEEP during noninvasive ventilation.

Group Type EXPERIMENTAL

The level of PEEP during noninvasive ventilation

Intervention Type 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.

Low PEEP group

Patients in low PEEP group will received 5 cmH2O of PEEP during noninvasive ventilation.

Group Type ACTIVE_COMPARATOR

The level of PEEP during noninvasive ventilation

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No