Noninvasive VentilationNCT05193786
Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure
A study testing Different level of PEEP in people with Noninvasive Ventilation, run by Chongqing Medical University at 1 site in China.
Trial summary
Current study aimed to explore the effect of high PEEP during noninvasive ventilation among hypoxemic patients with acute respiratory failure. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Noninvasive Ventilation
- What is being tested?
- Different level of PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- refusal of paticipation
- pregant woman
- requirement of emergency intubation
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing
About this study
Current study aimed to explore the effect of high PEEP during noninvasive ventilation among hypoxemic patients with acute respiratory failure.
Read the 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.
- Conditions
- Noninvasive Ventilation
- Being tested
- Different level of PEEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different level of PEEPProcedure or surgery
Different level of PEEP (low versus high) was applied in noninvasive ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Low PEEP group | Active comparator | In low PEEP group, the PEEP was 5 cmH2O and inspiratory pressure was 10-20 cmH2O in noninvasive ventilation. Receives: Procedure: Different level of PEEP |
| High PEEP group | Experimental | In high PEEP group, the PEEP was 10-15 cmH2O and inspiratory pressure was 15-20 cmH2O in noninvasive ventilation. Receives: Procedure: Different level of PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of noninvasive ventilation failure
Noninvasive ventilation failure was defined as intubation, death or withdrawal of therapy during noninvasive ventilation.
Measured: From randomization to 28 days of study
Secondary outcomes (7)
28-day mortality
Died within 28 days of study
Measured: From randomization to 28 days of study
Duration of noninvasive ventilation
The days spent on noninvasive ventilation
Measured: From beginning to 28 days of study
Duration of invasive mechanical ventilation
The days spent on invasive ventilation
Measured: From randomization to 28 days of study
Length of stay in ICU
The days spent in ICU
Measured: From beginning to 28 days of study
Length of stay in hospital
The days spent in hospital
Measured: From beginning to 28 days of study
The changes of PaO2/FiO2
Oxygenation was calculated as PaO2/FiO2.
Measured: From randomization to 28 days of study
Side effect
Side effect included the incidence of pressure ulcer, pneumothorax, vomitting, aspiration and dryness
Measured: From randomization to 28 days of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start11 Jan 2022
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Noninvasive VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Low versus high PEEP
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duan jun, Chongqing Medical University
- Investigators
- Jun Duan, Dr., Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193786
- Sponsor's protocol ID
- ChongqingMU5
- Status last verified
- Jan 2025
- First submitted
- 20 Dec 2021
- Last updated
- 24 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duan J, Liu X, Shu W, Tian S, Yang M, Ma M, Song A, Liu Q, Wang K, Yang F, Huang T, Jiang L, Hong Y, Han X, Ao Z, Bai L, Min Y, Hu W, He J. Low versus high positive end expiratory pressure in noninvasive ventilation for hypoxemic respiratory failure: a multicenter randomized controlled trial. Intensive Care Med. 2025 May;51(5):861-869. doi: 10.1007/s00134-025-07902-4. Epub 2025 Apr 30.
PubMed 40304742
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT05193786
- Acronym / sponsor ID
- ChongqingMU5
- Conditions
- Noninvasive Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Low versus high PEEP
| Arm | Type | Receives |
|---|---|---|
| Low PEEP group | Active comparator | Procedure: Different level of PEEPIn low PEEP group, the PEEP was 5 cmH2O and inspiratory pressure was 10-20 cmH2O in noninvasive ventilation. |
| High PEEP group | Experimental | Procedure: Different level of PEEPIn high PEEP group, the PEEP was 10-15 cmH2O and inspiratory pressure was 15-20 cmH2O in noninvasive ventilation. |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- age between 16 and 85 years
- use of dedicated noninvasive ventilator
- PaCO2 ≤50 mmHg
- PaO2/FiO2 ≤300mmHg
- expectation of noninvasive ventilation >12 hours
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Different level of PEEPDifferent level of PEEP (low versus high) was applied in noninvasive ventilation. | Procedure or surgery | High PEEP group, Low PEEP group |
Primary outcome
Rate of noninvasive ventilation failure
Time frame: From randomization to 28 days of study
Noninvasive ventilation failure was defined as intubation, death or withdrawal of therapy during noninvasive ventilation.
7 secondary outcomes
28-day mortality
Time frame: From randomization to 28 days of study
Duration of noninvasive ventilation
Time frame: From beginning to 28 days of study
Duration of invasive mechanical ventilation
Time frame: From randomization to 28 days of study
Length of stay in ICU
Time frame: From beginning to 28 days of study
Length of stay in hospital
Time frame: From beginning to 28 days of study
The changes of PaO2/FiO2
Time frame: From randomization to 28 days of study
Side effect
Time frame: From randomization to 28 days of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Derived from this study: PubMed 40304742Duan J, Liu X, Shu W, Tian S, Yang M, Ma M, Song A, Liu Q, Wang K, Yang F, Huang T, Jiang L, Hong Y, Han X, Ao Z, Bai L, Min Y, Hu W, He J. Low versus high positive end expiratory pressure in noninvasive ventilation for hypoxemic respiratory failure: a multicenter randomized controlled trial. Intensive Care Med. 2025 May;51(5):861-869. doi: 10.1007/s00134-025-07902-4. Epub 2025 Apr 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Duan, Dr. principal investigator
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different level of PEEP in people with Noninvasive Ventilation, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of noninvasive ventilation failure (time frame: From randomization to 28 days of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05193786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.