Mechanical VentilationPEEP-TESTNCT04023786
Positive End-expiratory Pressure Effects to Predict Fluid Responsiveness
A study testing PEEP-TEST and The VenArt System in people with Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Volume expansion is one of the main treatments for shock. A test to predict the effectiveness of volume expansion prior to administration would avoid the need for excess treatment if it proves to be unnecessary.PEEP test would be an easy alternative to the tests used in current practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- PEEP-TEST and The VenArt System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Dec 2019to 1 Jul 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Coverage by a health insurance scheme
- Patient under mechanical invasive ventilation (tracheal intubation)
- PEEP level ≥10 cmH2O
- Cardiac flow monitoring device in place by the PiCCO2 system (Pulsion Medical Systems, Feldkirch, Germany).
- Ikorus urinary catheter in place
- Decision by the doctors in charge of carrying out a passive leg raising test and / or a volume expansion
Who cannot join
- Pregnancy
- Participation in another interventional study
- Patients under the protection of justice
- Thoracic drainage (preventing PEP changes from inducing intrathoracic and transpulmonary pressure changes from their hemodynamic effects).
Trial locations and contacts
2 sites in 1 country.
France2 sites
Dr Alexandra Beurton
Le Kremlin-Bicêtre, Val de Marne
Dr Alexandra Beurton
Paris, 75651
About this study
Volume expansion is one of the main treatments for shock. A test to predict the effectiveness of volume expansion prior to administration would avoid the need for excess treatment if it proves to be unnecessary.PEEP test would be an easy alternative to the tests used in current practice.
Read the detailed description
Volume expansion is one of the main treatments for shock, with the goal of increasing cardiac preload and, consequently, cardiac output. However, this increase only occurs if there is a preload-dependence of cardiac output, which is present in 50% of cases. A test to predict the effectiveness of volume expansion prior to administration would avoid the need for excess treatment if it proves to be unnecessary. The end-expiratory pressure test (PEEP) would be to vary the PEEP in patients in shock conditions placed under mechanical ventilation. PEEP is the positive pressure maintained in the airways at the end of expiration. It opposes systemic venous return and lowers cardiac preload. It also distends the pulmonary vessels, increases their resistance and opposes the ejection of the right ventricle. The decrease in PEEP could alleviate the obstacle to venous return and thus increase cardiac preload, mimicking a volume expansion, increasing cardiac output only in the case of preload dependence. This test would be an easy alternative to the tests used in current practice. To evaluate the ability of the PEEP test to detect a preload-dependence condition, defined by a passive passive leg raising test, in patients in shock.
The primary endpoint will be the area under the receiver operating characteristic (ROC) curve constructed to describe the ability of the PEEP test to detect a preload-dependency condition. We measure cardiac output by analysis of the pulse wave contour before and after the passive leg raising and PEEP test tests, then according to these tests, measurement of the cardiac output before and after volume expansion.
- Conditions
- Mechanical Ventilation
- Being tested
- PEEP-TEST, The VenArt System
- Keywords
- PEEP test preload dependancy fluid responsiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP-TESTProcedure or surgery
The PEEP test will consist of lowering the PEEP level to 5 cmH2O for a maximum of 2 minutes and a minimum of 1 minute. Patients will be included if the physicians who care for them have decided to set a baseline PEEP level ≥10 cmH2O.
The VenArt SystemDevice
The VenArt System for estimating cardiac output (a patch stuck to the surface of the neck and a saturation sensor placed at the tip of a finger).
| Study group | Role | What they receive |
|---|---|---|
| 70 patients, one arm | Experimental | All patients benefits of a passive leg raising test and a PEEP test to compare these two tests. Receives: Procedure: PEEP-TEST; Device: The VenArt System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the PEP test to detect a preload-dependency condition.
The primary endpoint will be the area under the receiver operating characteristic (ROC) curve constructed to describe the ability of the PEP test to detect a preload-dependency condition.
Measured: At the end of the hospitalization in intensive care unit (1 month maximum)
Secondary outcomes (2)
Relationship between the ability of the PEEP test to detect a preload-dependancy and secondly the PEEP delta induced by the test
The secondary endpoint will be the relationship between the area under the curve constructed to describe the ability of the PEP test to detect a preload-dependency state and the PEP delta induced by the test (PEP starting, high, PEP during the test, at 5 cmH2O).
Measured: At the end of the hospitalization in intensive care unit (1 month maximum)
Ability of the PEP test to detect a response to volume expansion.
The secondary endpoint will be the area under the curve constructed to describe the ability of the PEP test to detect a response to volume expansion.
Measured: At the end of the hospitalization in intensive care unit (1 month maximum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start13 Dec 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023786
- Sponsor's protocol ID
- 2018-A01599-46
- Acronym
- PEEP-TEST
- Status last verified
- Feb 2026
- First submitted
- 8 Jul 2019
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive End-expiratory Pressure Effects to Predict Fluid Responsiveness
- ClinicalTrials.gov ID
- NCT04023786
- Acronym / sponsor ID
- PEEP-TEST / 2018-A01599-46
- Conditions
- Mechanical Ventilation
- Keywords
- PEEP test preload dependancy fluid responsiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 18 Jul 2019 (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.
Volume expansion is one of the main treatments for shock. A test to predict the effectiveness of volume expansion prior to administration would avoid the need for excess treatment if it proves to be unnecessary.PEEP test would be an easy alternative to the tests used in current practice.
Detailed description
Volume expansion is one of the main treatments for shock, with the goal of increasing cardiac preload and, consequently, cardiac output. However, this increase only occurs if there is a preload-dependence of cardiac output, which is present in 50% of cases. A test to predict the effectiveness of volume expansion prior to administration would avoid the need for excess treatment if it proves to be unnecessary. The end-expiratory pressure test (PEEP) would be to vary the PEEP in patients in shock conditions placed under mechanical ventilation. PEEP is the positive pressure maintained in the airways at the end of expiration. It opposes systemic venous return and lowers cardiac preload. It also distends the pulmonary vessels, increases their resistance and opposes the ejection of the right ventricle. The decrease in PEEP could alleviate the obstacle to venous return and thus increase cardiac preload, mimicking a volume expansion, increasing cardiac output only in the case of preload dependence. This test would be an easy alternative to the tests used in current practice. To evaluate the ability of the PEEP test to detect a preload-dependence condition, defined by a passive passive leg raising test, in patients in shock.
The primary endpoint will be the area under the receiver operating characteristic (ROC) curve constructed to describe the ability of the PEEP test to detect a preload-dependency condition. We measure cardiac output by analysis of the pulse wave contour before and after the passive leg raising and PEEP test tests, then according to these tests, measurement of the cardiac output before and after volume expansion.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 70 patients, one arm | Experimental | Procedure: PEEP-TEST, Device: The VenArt SystemAll patients benefits of a passive leg raising test and a PEEP test to compare these two tests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- Pregnancy
- Participation in another interventional study
- Patients under the protection of justice
- Thoracic drainage (preventing PEP changes from inducing intrathoracic and transpulmonary pressure changes from their hemodynamic effects).
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 |
|---|---|---|
| PEEP-TESTThe PEEP test will consist of lowering the PEEP level to 5 cmH2O for a maximum of 2 minutes and a minimum of 1 minute. Patients will be included if the physicians who care for them have decided to set a baseline PEEP level ≥10 cmH2O. | Procedure or surgery | 70 patients, one arm |
| The VenArt SystemThe VenArt System for estimating cardiac output (a patch stuck to the surface of the neck and a saturation sensor placed at the tip of a finger). | Device | 70 patients, one arm |
Primary outcome
Ability of the PEP test to detect a preload-dependency condition.
Time frame: At the end of the hospitalization in intensive care unit (1 month maximum)
The primary endpoint will be the area under the receiver operating characteristic (ROC) curve constructed to describe the ability of the PEP test to detect a preload-dependency condition.
2 secondary outcomes
Relationship between the ability of the PEEP test to detect a preload-dependancy and secondly the PEEP delta induced by the test
Time frame: At the end of the hospitalization in intensive care unit (1 month maximum)
Ability of the PEP test to detect a response to volume expansion.
Time frame: At the end of the hospitalization in intensive care unit (1 month maximum)
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 11 Feb 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP-TEST and The VenArt System in people with Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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 7 inclusion and 4 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 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Ability of the PEP test to detect a preload-dependency condition. (time frame: At the end of the hospitalization in intensive care unit (1 month maximum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2026.