High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChongqing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years

PaO2/FiO2 ≤300 mmHg or SpO2/FiO2 ≤315(SpO2 ≤97%)

Anticipated NIV duration > 12 h

Preserved consciousness (GCS≥13)

Disqualifiers

Use of NIV > 24 h before randomization

Acute-on-chronic respiratory failure

Congestive heart failure

Use of NIV after extubation (within 48 hours)

Trial design

Design model

Parallel

Treatments tested in this trial

  • The level of PEEP during noninvasive ventilation

    Procedure/Surgery

    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.

Treatment groups

706 Participants
are divided into 2 treatment groups
Group A: High PEEP groupExperimental treatment 1 intervention
Group B: Low PEEP groupActive comparator 1 intervention

Trial outcomes

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

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

Time frame
from randomization to 28 days after randomization
3

28-day survival

Time frame
from randomization to 28 days after randomization
4

7-category ordinal scale for clinical improvement at 28 days

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.

Time frame
from randomization to 28 days after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chongqing Medical University

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Sponsor institution