Acute Respiratory Distress SyndromeELSENCT03281473
Comparison of Positive End Expiratory Pressure Titration Methods in ARDS Patients
A study testing Strategy 1 and Strategy 2 in people with Acute Respiratory Distress Syndrome, run by University Hospital, Angers at 1 site in France.
Trial summary
This study aims at assessing the short-term physiological effects of 2 positive end expiratory pressure titration strategies in patients with ARDS. 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?
- Strategy 1 and Strategy 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2018to Dec 2019
- 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
- Moderate or severe ARDS
- Consent to participation obtained from a relative
Who cannot join
- Protect adult
- Pregnant or breastfeeding woman
- No-affiliation to the social security scheme
- Contra-indication to the placement of an esophageal pressure measuring catheter
- Pneumothorax
- Hemodynamic and / or respiratory instability
- Extra-corporeal membrane oxygenation
Trial locations and contacts
1 site in 1 country.
Study Official is required by the WHO and BELONCLE, Ass.Pr contact
France1 site, 1 recruiting
- Recruiting
University Hospital
Angers
François BELONCLE, Ass.Pr, 0241353845, Francois.Beloncle@chu-angers.fr
About this study
Official title: Comparison of Positive End Expiratory Pressure Titration Methods in Patients With Acute Respiratory Distress Syndrome: a Physiological Study
This study aims at assessing the short-term physiological effects of 2 positive end expiratory pressure titration strategies in patients with ARDS.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Strategy 1, Strategy 2
- Keywords
- ARDS, Esophageal pressure, Mechanical ventilation
- 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.
Strategy 1Other
PEEP titration according to transpulmonary-end-expiratory pressure
Strategy 2Other
PEEP titration according to chest wall elastance measurement
| Study group | Role | What they receive |
|---|---|---|
| Arms A | Experimental | Strategy 1 - Washout period - Strategy 2 Receives: Other: Strategy 1; Other: Strategy 2 |
| Arms B | Experimental | Strategy 2 - Washout period - Strategy 1 Receives: Other: Strategy 1; Other: Strategy 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term effects of 2 PEEP titration strategies on gas exchange
Measured: 2 hours 15 minutes
Secondary outcomes (2)
Short-term effects of 2 PEEP titration strategies on respiratory mechanics
Measured: 2 hours 15 min
Short-term effects of 2 PEEP titration strategies on hemodynamics
Measured: 2 hours 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start2 Oct 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
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 Acute Respiratory Distress SyndromeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Study Official is required by the WHO and BELONCLE, Ass.Pr, Principal investigator, Angers teatching hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281473
- Sponsor's protocol ID
- 49RC17_0220
- Acronym
- ELSE
- Status last verified
- Mar 2019
- First submitted
- 11 Jul 2017
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chean D, Courtais A, Pavlovsky B, Yvin E, Desprez C, Taillantou-Candau M, Piquilloud L, Richard JC, Mercat A, Beloncle FM. Comparison of two transpulmonary pressure-based positive end-expiratory pressure titration strategies in acute respiratory distress syndrome: a randomized crossover study. Crit Care. 2025 Sep 29;29(1):409. doi: 10.1186/s13054-025-05626-x.
PubMed 41024114
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Positive End Expiratory Pressure Titration Methods in Patients With Acute Respiratory Distress Syndrome: a Physiological Study
- ClinicalTrials.gov ID
- NCT03281473
- Acronym / sponsor ID
- ELSE / 49RC17_0220
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, Esophageal pressure, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 13 Sep 2017 (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.
This study aims at assessing the short-term physiological effects of 2 positive end expiratory pressure titration strategies in patients with ARDS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arms A | Experimental | Other: Strategy 1, Other: Strategy 2Strategy 1 - Washout period - Strategy 2 |
| Arms B | Experimental | Other: Strategy 1, Other: Strategy 2Strategy 2 - Washout period - Strategy 1 |
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
- Moderate or severe ARDS
- Consent to participation obtained from a relative
Key exclusion criteria (7 listed)
- Protect adult
- Pregnant or breastfeeding woman
- No-affiliation to the social security scheme
- Contra-indication to the placement of an esophageal pressure measuring catheter
- 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 |
|---|---|---|
| Strategy 1PEEP titration according to transpulmonary-end-expiratory pressure | Other | Arms A, Arms B |
| Strategy 2PEEP titration according to chest wall elastance measurement | Other | Arms A, Arms B |
Primary outcome
Short-term effects of 2 PEEP titration strategies on gas exchange
Time frame: 2 hours 15 minutes
2 secondary outcomes
Short-term effects of 2 PEEP titration strategies on respiratory mechanics
Time frame: 2 hours 15 min
Short-term effects of 2 PEEP titration strategies on hemodynamics
Time frame: 2 hours 15 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Derived from this study: PubMed 41024114Chean D, Courtais A, Pavlovsky B, Yvin E, Desprez C, Taillantou-Candau M, Piquilloud L, Richard JC, Mercat A, Beloncle FM. Comparison of two transpulmonary pressure-based positive end-expiratory pressure titration strategies in acute respiratory distress syndrome: a randomized crossover study. Crit Care. 2025 Sep 29;29(1):409. doi: 10.1186/s13054-025-05626-x.
- 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.
Study Official is required by the WHO and BELONCLE, Ass.Pr contact
Study Official is required by the WHO and BELONCLE, Ass.Pr principal investigator
Angers teatching hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategy 1 and Strategy 2 in people with Acute Respiratory Distress Syndrome, 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 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: status not confirmed, as of the sponsor's last update on 21 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Study Official is required by the WHO and BELONCLE, Ass.Pr (0241353845, Francois.Beloncle@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term effects of 2 PEEP titration strategies on gas exchange (time frame: 2 hours 15 minutes). 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 NCT03281473, 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 21 Mar 2019.