Respiratory Failure With HypoxiaNCT07503509
Physiological Study of High PEEP in Noninvasive Ventilation
A study testing high PEEP in people with Respiratory Failure With Hypoxia, run by Chongqing Medical University at 1 site in China.
Trial summary
To investigate the physiological effects of high positive end-expiratory pressure (PEEP) during noninvasive ventilation in patients with hypoxemic respiratory failure, and to elucidate the mechanisms underlying high PEEP-induced improvement in oxygenation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Respiratory Failure With Hypoxia
- What is being tested?
- high PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- PaCO₂ ≤ 50 mmHg
- PaO₂/FiO₂ ≤ 300 mmHg
- Use of a noninvasive ventilator with esophageal pressure monitoring capability (e.g., Mindray SV70) -
Who cannot join
- Respiratory failure caused by heart failure, asthma, or acute exacerbation of chronic obstructive pulmonary disease (COPD) (COPD as a comorbidity may be included)
- Pneumothorax
- Patients who refuse to participate in this trial -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Jun Duan, 86-023-89012680, duanjun412589@163.com
About this study
Official title: A Physiological Study of High PEEP During Noninvasive Ventilation in Patients With Hypoxemic Respiratory Failure
To investigate the physiological effects of high positive end-expiratory pressure (PEEP) during noninvasive ventilation in patients with hypoxemic respiratory failure, and to elucidate the mechanisms underlying high PEEP-induced improvement in oxygenation.
- Conditions
- Respiratory Failure With Hypoxia
- Being tested
- high PEEP
- Keywords
- noninvasive ventilation, PEEP, respiratory failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high PEEPProcedure or surgery
First, PEEP was set at 5 cmH₂O, and inspiratory pressure was adjusted to achieve a target tidal volume of 6-8 mL/kg. Fraction of inspired oxygen (FiO₂) was titrated to maintain peripheral oxygen saturation (SpO₂) between 88% and 92%. Subsequently, PEEP was increased in 5 cmH₂O increments every 10-20 minutes from the initial value of 5 cmH₂O. Once PEEP reached 20 cmH₂O or above, increments were made every 3-5 minutes until the recruitment level was achieved (i.e., PEEP was increased stepwise from 5 to 10, 15, 20, 25, and 30 cmH₂O). Inspiratory pressure was adjusted concurrently to maintain a constant pressure difference. Throughout the procedure, physiological parameters-including respiratory rate, oxygenation, work of breathing, and others-were collected.
| Study group | Role | What they receive |
|---|---|---|
| High PEEP group | Experimental | PEEP is increased stepwise from 5 cmH₂O, with increments of 5 cmH₂O every 10-20 minutes until reaching 20 cmH₂O. Once PEEP reaches or exceeds 20 cmH₂O, increments are made every 3-5 minutes until the recruitment level is achieved (i.e., stepwise increases to 5, 10, 15, 20, 25, and 30 cmH₂O). Inspiratory pressure is adjusted simultaneously to maintain a constant pressure difference. Receives: Procedure: high PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation
The changes of SpO2/FiO2 from 5 to 30 cmH2O of PEEP.
Measured: From enrollment to 2 hours post-intervention
Secondary outcomes (8)
Respiratory rate
Changes of respiratory rate from 5 to 30 cmH2O of PEEP
Measured: From enrollment to 2 hours post-intervention
Blood pressure
Changes of blood pressure from 5 to 30 cmH2O of PEEP
Measured: From enrollment to 2 hours post-intervention
Heart rate
Changes of heart rate from 5 to 30 cmH2O of PEEP
Measured: From enrollment to 2 hours post-intervention
Diaphragmatic excursion
Changes in diaphragmatic excursion across PEEP levels from 5 to 30 cmH₂O. Diaphragmatic excursion refers to the movement of the thoracic diaphragm during breathing, as assessed by ultrasound.
Measured: From enrollment to 2 hours post-intervention
Diaphragm thickening fraction
Changes in diaphragm thickening fraction across PEEP levels from 5 to 30 cmH₂O. Diaphragm thickening fraction is calculated based on the change in diaphragm thickness from end-expiration to end-inspiration ([end-inspiration - end-expiration]/end-expiration), as assessed by ultrasound.
Measured: From enrollment to 2 hours post-intervention
Work of breathing
Changes in work of breathing across PEEP levels ranging from 5 to 30 cmH₂O were assessed by monitoring esophageal pressure with an esophageal balloon catheter.
Measured: From enrollment to 2 hours post-intervention
Electrical impedance tomography of the lung
Changes in lung electrical impedance tomography were recorded across PEEP levels ranging from 5 to 30 cmH₂O. The electrical impedance tomography belt was placed around the chest at the level of the 4th to 5th intercostal spaces, and data were collected after the patient's breathing had stabilized.
Measured: From enrollment to 2 hours post-intervention
Tidal volume
Changes of tidal volume from 5 to 30 cmH2O of PEEP
Measured: From enrollment to 2 hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start26 Mar 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory Failure With HypoxiaStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
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, MD, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503509
- Sponsor's protocol ID
- ChongqingMU07
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The informed consent form for this study clearly states that patients' data are only accessible to the research team and regulatory authorities when necessary, and shall not be disclosed to other individuals or institutions.Therefore, there is no plan to make data publicly available for this study.
Publications
L'Her E, Deye N, Lellouche F, Taille S, Demoule A, Fraticelli A, Mancebo J, Brochard L. Physiologic effects of noninvasive ventilation during acute lung injury. Am J Respir Crit Care Med. 2005 Nov 1;172(9):1112-8. doi: 10.1164/rccm.200402-226OC. Epub 2005 Aug 4.
PubMed 16081548Yoshida T, Roldan R, Beraldo MA, Torsani V, Gomes S, De Santis RR, Costa EL, Tucci MR, Lima RG, Kavanagh BP, Amato MB. Spontaneous Effort During Mechanical Ventilation: Maximal Injury With Less Positive End-Expiratory Pressure. Crit Care Med. 2016 Aug;44(8):e678-88. doi: 10.1097/CCM.0000000000001649.
PubMed 27002273Morais CCA, Koyama Y, Yoshida T, Plens GM, Gomes S, Lima CAS, Ramos OPS, Pereira SM, Kawaguchi N, Yamamoto H, Uchiyama A, Borges JB, Vidal Melo MF, Tucci MR, Amato MBP, Kavanagh BP, Costa ELV, Fujino Y. High Positive End-Expiratory Pressure Renders Spontaneous Effort Noninjurious. Am J Respir Crit Care Med. 2018 May 15;197(10):1285-1296. doi: 10.1164/rccm.201706-1244OC.
PubMed 29323536Duan J, Han X, Bai L, Zhou L, Huang S. Assessment of heart rate, acidosis, consciousness, oxygenation, and respiratory rate to predict noninvasive ventilation failure in hypoxemic patients. Intensive Care Med. 2017 Feb;43(2):192-199. doi: 10.1007/s00134-016-4601-3. Epub 2016 Nov 3.
PubMed 27812731
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physiological Study of High PEEP During Noninvasive Ventilation in Patients With Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT07503509
- Acronym / sponsor ID
- ChongqingMU07
- Conditions
- Respiratory Failure With Hypoxia
- Keywords
- noninvasive ventilation, PEEP, respiratory failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 31 Mar 2026 (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.
To investigate the physiological effects of high positive end-expiratory pressure (PEEP) during noninvasive ventilation in patients with hypoxemic respiratory failure, and to elucidate the mechanisms underlying high PEEP-induced improvement in oxygenation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High PEEP group | Experimental | Procedure: high PEEPPEEP is increased stepwise from 5 cmH₂O, with increments of 5 cmH₂O every 10-20 minutes until reaching 20 cmH₂O. Once PEEP reaches or exceeds 20 cmH₂O, increments are made every 3-5 minutes until the recruitment level is achieved (i.e., stepwise increases to 5, 10, 15, 20, 25, and 30 cmH₂O). Inspiratory pressure is adjusted simultaneously to maintain a constant pressure difference. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- PaCO₂ ≤ 50 mmHg
- PaO₂/FiO₂ ≤ 300 mmHg
- Use of a noninvasive ventilator with esophageal pressure monitoring capability (e.g., Mindray SV70) -
Key exclusion criteria (3 listed)
- Respiratory failure caused by heart failure, asthma, or acute exacerbation of chronic obstructive pulmonary disease (COPD) (COPD as a comorbidity may be included)
- Pneumothorax
- Patients who refuse to participate in this trial -
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 |
|---|---|---|
| high PEEPFirst, PEEP was set at 5 cmH₂O, and inspiratory pressure was adjusted to achieve a target tidal volume of 6-8 mL/kg. Fraction of inspired oxygen (FiO₂) was titrated to maintain peripheral oxygen saturation (SpO₂) between 88% and 92%. Subsequently, PEEP was increased in 5 cmH₂O increments every 10-20 minutes from the initial value of 5 cmH₂O. Once PEEP reached 20 cmH₂O or above, increments were made every 3-5 minutes until the recruitment level was achieved (i.e., PEEP was increased stepwise from 5 to 10, 15, 20, 25, and 30 cmH₂O). Inspiratory pressure was adjusted concurrently to maintain a constant pressure difference. Throughout the procedure, physiological parameters-including respiratory rate, oxygenation, work of breathing, and others-were collected. | Procedure or surgery | High PEEP group |
Primary outcome
Oxygenation
Time frame: From enrollment to 2 hours post-intervention
The changes of SpO2/FiO2 from 5 to 30 cmH2O of PEEP.
8 secondary outcomes
Respiratory rate
Time frame: From enrollment to 2 hours post-intervention
Blood pressure
Time frame: From enrollment to 2 hours post-intervention
Heart rate
Time frame: From enrollment to 2 hours post-intervention
Diaphragmatic excursion
Time frame: From enrollment to 2 hours post-intervention
Diaphragm thickening fraction
Time frame: From enrollment to 2 hours post-intervention
Work of breathing
Time frame: From enrollment to 2 hours post-intervention
Electrical impedance tomography of the lung
Time frame: From enrollment to 2 hours post-intervention
Tidal volume
Time frame: From enrollment to 2 hours post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Results publication: PubMed 16081548L'Her E, Deye N, Lellouche F, Taille S, Demoule A, Fraticelli A, Mancebo J, Brochard L. Physiologic effects of noninvasive ventilation during acute lung injury. Am J Respir Crit Care Med. 2005 Nov 1;172(9):1112-8. doi: 10.1164/rccm.200402-226OC. Epub 2005 Aug 4.
- Results publication: PubMed 27002273Yoshida T, Roldan R, Beraldo MA, Torsani V, Gomes S, De Santis RR, Costa EL, Tucci MR, Lima RG, Kavanagh BP, Amato MB. Spontaneous Effort During Mechanical Ventilation: Maximal Injury With Less Positive End-Expiratory Pressure. Crit Care Med. 2016 Aug;44(8):e678-88. doi: 10.1097/CCM.0000000000001649.
- Results publication: PubMed 29323536Morais CCA, Koyama Y, Yoshida T, Plens GM, Gomes S, Lima CAS, Ramos OPS, Pereira SM, Kawaguchi N, Yamamoto H, Uchiyama A, Borges JB, Vidal Melo MF, Tucci MR, Amato MBP, Kavanagh BP, Costa ELV, Fujino Y. High Positive End-Expiratory Pressure Renders Spontaneous Effort Noninjurious. Am J Respir Crit Care Med. 2018 May 15;197(10):1285-1296. doi: 10.1164/rccm.201706-1244OC.
- Results publication: PubMed 27812731Duan J, Han X, Bai L, Zhou L, Huang S. Assessment of heart rate, acidosis, consciousness, oxygenation, and respiratory rate to predict noninvasive ventilation failure in hypoxemic patients. Intensive Care Med. 2017 Feb;43(2):192-199. doi: 10.1007/s00134-016-4601-3. Epub 2016 Nov 3.
- Individual participant dataSharing planned: No. The informed consent form for this study clearly states that patients' data are only accessible to the research team and regulatory authorities when necessary, and shall not be disclosed to other individuals or institutions.Therefore, there is no plan to make data publicly available for this study.
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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.
Jun Duan, MD 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 high PEEP in people with Respiratory Failure With Hypoxia, 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 31 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Duan (+86-89012680, duanjun412589@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation (time frame: From enrollment to 2 hours post-intervention). 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 NCT07503509, which also lists 4 linked publications.
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 31 Mar 2026.