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Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure

Primary Purpose

Noninvasive Ventilation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Different level of PEEP
Sponsored by
Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Noninvasive Ventilation

Eligibility Criteria

16 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Low PEEP group

High PEEP group

Arm Description

In low PEEP group, the PEEP was 5 cmH2O and inspiratory pressure was 10-20 cmH2O in noninvasive ventilation.

In high PEEP group, the PEEP was 10-15 cmH2O and inspiratory pressure was 15-20 cmH2O in noninvasive ventilation.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

28-day mortality
Died within 28 days of study
Duration of noninvasive ventilation
The days spent on noninvasive ventilation
Duration of invasive mechanical ventilation
The days spent on invasive ventilation
Length of stay in ICU
The days spent in ICU
Length of stay in hospital
The days spent in hospital
The changes of PaO2/FiO2
Oxygenation was calculated as PaO2/FiO2.
Side effect
Side effect included the incidence of pressure ulcer, pneumothorax, vomitting, aspiration and dryness

Full Information

First Posted
December 20, 2021
Last Updated
April 18, 2023
Sponsor
Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05193786
Brief Title
Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure
Official Title
Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chongqing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noninvasive Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Low versus high PEEP
Masking
None (Open Label)
Allocation
Randomized
Enrollment
348 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low PEEP group
Arm Type
Active Comparator
Arm Description
In low PEEP group, the PEEP was 5 cmH2O and inspiratory pressure was 10-20 cmH2O in noninvasive ventilation.
Arm Title
High PEEP group
Arm Type
Experimental
Arm Description
In high PEEP group, the PEEP was 10-15 cmH2O and inspiratory pressure was 15-20 cmH2O in noninvasive ventilation.
Intervention Type
Procedure
Intervention Name(s)
Different level of PEEP
Intervention Description
Different level of PEEP (low versus high) was applied in noninvasive ventilation.
Primary Outcome Measure Information:
Title
Rate of noninvasive ventilation failure
Description
Noninvasive ventilation failure was defined as intubation, death or withdrawal of therapy during noninvasive ventilation.
Time Frame
From randomization to 28 days of study
Secondary Outcome Measure Information:
Title
28-day mortality
Description
Died within 28 days of study
Time Frame
From randomization to 28 days of study
Title
Duration of noninvasive ventilation
Description
The days spent on noninvasive ventilation
Time Frame
From beginning to 28 days of study
Title
Duration of invasive mechanical ventilation
Description
The days spent on invasive ventilation
Time Frame
From randomization to 28 days of study
Title
Length of stay in ICU
Description
The days spent in ICU
Time Frame
From beginning to 28 days of study
Title
Length of stay in hospital
Description
The days spent in hospital
Time Frame
From beginning to 28 days of study
Title
The changes of PaO2/FiO2
Description
Oxygenation was calculated as PaO2/FiO2.
Time Frame
From randomization to 28 days of study
Title
Side effect
Description
Side effect included the incidence of pressure ulcer, pneumothorax, vomitting, aspiration and dryness
Time Frame
From randomization to 28 days of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Duan, Dr.
Phone
+8615023077940
Email
duanjun412589@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Duan, Dr.
Organizational Affiliation
First Affiliated Hospital of Chongqing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Duan, Dr
Phone
89012017
Email
duanjun412589@163.com
First Name & Middle Initial & Last Name & Degree
Linfu Bai
Phone
89012680
Email
1023762525@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure

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