Acute Respiratory Distress SyndromeDISTIE-DVNCT06536543
EIT Assessment of Overdistension in ARDS Patients in Prone Position
An observational study of Acute Respiratory Distress Syndrome, run by University Hospital, Bordeaux at 2 sites in France.
Trial summary
Mechanical ventilation in ARDS requires protective ventilation with low VT and PEEP. PEEP titration can improve lung recruitment in the dependent lung but with a risk of overdistension in the non-dependant lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Acute Respiratory Distress Syndrom (ARDS) treated with Prone Position (PP) equipped with Electrical Impedance Tomography (EIT)
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Oct 2024to May 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalised in the thoracic intensive care unit, with moderate or severe ARDS according to the Berlin criteria, requiring a prone position, treated with PP equipped with EIT, will be included.
Who may be able to join
- Patients hospitalized in the ICU and who suffered moderate or severe ARDS (Berlin criteria, PaO2/FiO2<150), intubated sedated, under myorelaxant and equipped with EIT
- Over the age of 18.
Who cannot join
- Broncho-pleural leaks
- Pregnant or breastfeeding woman.
- Guardianship or curatorship
- Deprived of liberty
- No health insurance
- Impossibility to correctly position the EIT belt (e.g., dressings, chest drainage, etc.)
- Contra indications to EIT (e.g., implantable cardiac defibrillator, pacemaker, instable spinal lesions)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CH Cote Basque
Bayonne, 64000
Hadrien ROZE, Pr, 0559443612 ext. +33, hroze@ch-cotebasque.fr
- Recruiting
Hopital Haut-Lévêque
Pessac, 33604
Benjamin REPUSSEAU, Dr, 05 57 65 68 66 ext. +33, benjamin.repusseau@chu-bordeaux.fr
About this study
Official title: Pulmonary Overdistension Assessment With Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrom in Prone Position
Mechanical ventilation in ARDS requires protective ventilation with low VT and PEEP. PEEP titration can improve lung recruitment in the dependent lung but with a risk of overdistension in the non-dependant lung. EIT can measure the distribution of tidal ventilation and assess overdistension and collapse during a PEEP titration in any position (prone or not).
This study aims to measure the best PEEP as a compromise between recruitment and overdistension during a PEEP trial with EIT before and just after PP.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Acute Respiratory Distress Syndrom (ARDS) treated with Prone Position (PP) equipped with Electrical Impedance Tomography (EIT)
- Keywords
- Ventilation Induced Lung Injury, lung overdistension, lung collapse, Electrical Impedance Tomography, Pressure Volume curve, Prone Position
- Medical subject headings
- Respiratory Distress Syndrome, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Respiratory Distress Syndrom (ARDS) treated with Prone Position (PP) equipped with Electrical Impedance Tomography (EIT)Other
Positive End-Expiratory Pressure (PEEP) will be titrated with PEEP-EIT method as it is already done in usual care. A classical low flow Pression Volume (PV) curve will be done in order to detect airway closure and measure compliance, the acquisition of EIT data during PV curve will be analysed secondary with a dedicated software. Reconstruction of EIT derived PV curve will determine the regional airway opening pressures and compliances of the 2 lungs. Two decremental PEEP-EIT titrations will be compared, one in supine and the other just after turning in prone.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with moderate or severe ARDS treated with PP equipped with EIT will be included.
Measurement of EIT data and ventilator spirometry in supine position and just after turning the patient in PP during a decremental PEEP-EIT titration, will be done, and blood gases and finally haemodynamic data Receives: Other: Acute Respiratory Distress Syndrom (ARDS) treated with Prone Position (PP) equipped with Electrical Impedance Tomography (EIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of distension
Assessing the level of distension when titrating the optimal PEEP in the supine position (SP) and in the PP position the first and second day of ARDS in PP. The measure will be obtained thanks to the crossing in EIT of the overdistension curve and the collapse curve when the PEEP is reduced from 20 to 5 cmH2O.
Measured: 48 hours after inclusion day
Secondary outcomes (2)
Comparison of the percent of overdistension and collapse during the EIT-PEEP titration
Thanks to PEEP-EIT titration in PP and SP the percent of collapse and global over-distension in EIT will be evaluate.
Measured: 48 hours after inclusion day
Repartition of regional ventilation in each part of the lungs.
Thanks to PV-EIT curve, the measurement of regional Airway Opening Pressure (anterior vs posterior) will be evaluate (lower inflection point of the PV-EIT curve).
Measured: 48 hours after inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start15 Oct 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536543
- Sponsor's protocol ID
- CHUBX 2022/13
- Acronym
- DISTIE-DV
- Status last verified
- Jan 2026
- First submitted
- 26 Jul 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Overdistension Assessment With Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrom in Prone Position
- ClinicalTrials.gov ID
- NCT06536543
- Acronym / sponsor ID
- DISTIE-DV / CHUBX 2022/13
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Ventilation Induced Lung Injury, lung overdistension, lung collapse, Electrical Impedance Tomography, Pressure Volume curve, Prone Position
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 5 Aug 2024 (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.
Mechanical ventilation in ARDS requires protective ventilation with low VT and PEEP. PEEP titration can improve lung recruitment in the dependent lung but with a risk of overdistension in the non-dependant lung. EIT can measure the distribution of tidal ventilation and assess overdistension and collapse during a PEEP titration in any position (prone or not).
This study aims to measure the best PEEP as a compromise between recruitment and overdistension during a PEEP trial with EIT before and just after PP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Acute Respiratory Distress Syndrom (ARDS) treated with Prone Position (PP) equipped with Electrical Impedance Tomography (EIT)Patients with moderate or severe ARDS treated with PP equipped with EIT will be included. Measurement of EIT data and ventilator spirometry in supine position and just after turning the patient in PP during a decremental PEEP-EIT titration, will be done, and blood gases and finally haemodynamic data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalised in the thoracic intensive care unit, with moderate or severe ARDS according to the Berlin criteria, requiring a prone position, treated with PP equipped with EIT, will be included.
Key inclusion criteria (2 listed)
- Patients hospitalized in the ICU and who suffered moderate or severe ARDS (Berlin criteria, PaO2/FiO2<150), intubated sedated, under myorelaxant and equipped with EIT
- Over the age of 18.
Key exclusion criteria (7 listed)
- Broncho-pleural leaks
- Pregnant or breastfeeding woman.
- Guardianship or curatorship
- Deprived of liberty
- No health insurance
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 |
|---|---|---|
| Acute Respiratory Distress Syndrom (ARDS) treated with Prone Position (PP) equipped with Electrical Impedance Tomography (EIT)Positive End-Expiratory Pressure (PEEP) will be titrated with PEEP-EIT method as it is already done in usual care. A classical low flow Pression Volume (PV) curve will be done in order to detect airway closure and measure compliance, the acquisition of EIT data during PV curve will be analysed secondary with a dedicated software. Reconstruction of EIT derived PV curve will determine the regional airway opening pressures and compliances of the 2 lungs. Two decremental PEEP-EIT titrations will be compared, one in supine and the other just after turning in prone. | Other | Study group |
Primary outcome
Level of distension
Time frame: 48 hours after inclusion day
Assessing the level of distension when titrating the optimal PEEP in the supine position (SP) and in the PP position the first and second day of ARDS in PP. The measure will be obtained thanks to the crossing in EIT of the overdistension curve and the collapse curve when the PEEP is reduced from 20 to 5 cmH2O.
2 secondary outcomes
Comparison of the percent of overdistension and collapse during the EIT-PEEP titration
Time frame: 48 hours after inclusion day
Repartition of regional ventilation in each part of the lungs.
Time frame: 48 hours after inclusion day
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 15 Jan 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by University Hospital, Bordeaux 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 2 inclusion and 7 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 15 Jan 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?
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 Benjamin REPUSSEAU, Dr (05 57 65 68 66 ext. +33, benjamin.repusseau@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of distension (time frame: 48 hours after inclusion day). 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 15 Jan 2026.