ARDS, HumanPULMOESONCT05337059
Feasabilty and Physiological Effects of a Ventilation Strategy Combining PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures in ARDS Patients.
A study testing PEEP and Tidal Volume Titration in people with ARDS, Human, run by University Hospital, Angers at 1 site in France.
Trial summary
Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human
- What is being tested?
- PEEP and Tidal Volume Titration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2022to 1 Apr 2026
- 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 or older
- Moderate to severe ARDS
- Written informed consent obtained from patient' surrogates
Who cannot join
- Pneumothorax
- Known pregnancy
- Contraindication to electrical impedance tomography or esophageal pressure measurements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasabilty and Physiological Effects of a Ventilation Strategy Combining PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures in ARDS Patients..
Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.
Read the detailed description
Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. A positive expiratory transpulmonary pressure may be considered as a target to limt the risk of collapse in dependant lung regions. Some authors propose to titrate PEEP to target an inspiratory transpulmonary pressure of 20cmH20 to limit the risk of overdistension in non-dependant regions.The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.
- Conditions
- ARDS, Human
- Being tested
- PEEP and Tidal Volume Titration
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP and Tidal Volume TitrationOther
PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures
| Study group | Role | What they receive |
|---|---|---|
| Transpulmonary based ventilation strategy | Experimental | PEEP and tidal volume will be set to target expiratory and inspiratory transpulmonary pressures of 0 and 20 cmH2O, respectively. Receives: Other: PEEP and Tidal Volume Titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation strategy failure
Number of patients with failure criteria (barotrauma, hemodynamic failure, rescue therapy or acidemia)
Measured: 48 hours
Secondary outcomes (8)
Short term physiologicals effects on hemodynamics
Cardiac index assed by Echocardiography (L/min/m^2)
Measured: 45 minutes
All-cause mortality at day 28
All-cause mortality
Measured: 28 days
Ventilator-free days at day 28
Number of alive ventilator free days
Measured: 28 days
Short term physiologicals effects on respiratory mechanics
recruited lung volume (mL)
Measured: 45 minutes
Short term physiologicals effects on gas exchange
PaO2/FiO2 ratio (mmHg)
Measured: 45 minutes
Short term physiologicals effects on gas exchange
VD/VT
Measured: 45 minutes
Short term physiologicals effects on gas exchange
PaCO2 (mmHg)
Measured: 45 minutes
Short term physiologicals effects on respiratory mechanics
distribution of ventilation assed by electrical impedance tomography (COV, %)
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start30 Mar 2022
- Primary completion4 Mar 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- feasibility, monocentric, prospective study
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337059
- Sponsor's protocol ID
- 2019-A03242-55
- Acronym
- PULMOESO
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2022
- Last updated
- 14 Apr 2026
- Results posted
- 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasabilty and Physiological Effects of a Ventilation Strategy Combining PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures in ARDS Patients..
- ClinicalTrials.gov ID
- NCT05337059
- Acronym / sponsor ID
- PULMOESO / 2019-A03242-55
- Conditions
- ARDS, Human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 20 Apr 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.
Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.
Detailed description
Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. A positive expiratory transpulmonary pressure may be considered as a target to limt the risk of collapse in dependant lung regions. Some authors propose to titrate PEEP to target an inspiratory transpulmonary pressure of 20cmH20 to limit the risk of overdistension in non-dependant regions.The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- feasibility, monocentric, prospective study
| Arm | Type | Receives |
|---|---|---|
| Transpulmonary based ventilation strategy | Experimental | Other: PEEP and Tidal Volume TitrationPEEP and tidal volume will be set to target expiratory and inspiratory transpulmonary pressures of 0 and 20 cmH2O, respectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Moderate to severe ARDS
- Written informed consent obtained from patient' surrogates
Key exclusion criteria (3 listed)
- Pneumothorax
- Known pregnancy
- Contraindication to electrical impedance tomography or esophageal pressure measurements
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 and Tidal Volume TitrationPEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures | Other | Transpulmonary based ventilation strategy |
Primary outcome
Ventilation strategy failure
Time frame: 48 hours
Number of patients with failure criteria (barotrauma, hemodynamic failure, rescue therapy or acidemia)
8 secondary outcomes
Short term physiologicals effects on hemodynamics
Time frame: 45 minutes
All-cause mortality at day 28
Time frame: 28 days
Ventilator-free days at day 28
Time frame: 28 days
Short term physiologicals effects on respiratory mechanics
Time frame: 45 minutes
Short term physiologicals effects on gas exchange
Time frame: 45 minutes
Short term physiologicals effects on gas exchange
Time frame: 45 minutes
Short term physiologicals effects on gas exchange
Time frame: 45 minutes
Short term physiologicals effects on respiratory mechanics
Time frame: 45 minutes
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 14 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP and Tidal Volume Titration in people with ARDS, Human, run by University Hospital, Angers at 1 site 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 3 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: finished, as of the sponsor's last update on 14 Apr 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 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?
Ventilation strategy failure (time frame: 48 hours). 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 14 Apr 2026.