ARDS (Acute Respiratory Distress Syndrome)FORWARDNCT06876415
Free for Weaning ECMO vs Respiratory Driven Study
A study testing P0.1 and delta Poeso integration into the decanulation decision in people with ARDS (Acute Respiratory Distress Syndrome), run by Assistance Publique Hopitaux De Marseille at 4 sites in France.
Trial summary
In its most severe form, Acute Respiratory Distress Syndrome (ARDS) may require the use of veno-venous ECMO (vvECMO). While the criteria for vvECMO indication, ECMO settings, and ventilator management are relatively well-defined after the publication of the EOLIA trial and subsequent national or international… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- P0.1 and delta Poeso integration into the decanulation decision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesFrance
- Study dates
- 29 Jul 2025to Sep 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older Patient whose trusted person has given consent for participation in the study
- Patient on veno-venous ECMO with weaning criteria, including:
- Resolution of the cause of ARDS
- Absence of hemodynamic instability, defined as norepinephrine dose ≤ 0.5 μg/kg/min for at least 3 hours
- Use of a ventilatory mode that allows spontaneous ventilation (VS-AI, BiPAP, or APRV)
- Maximum inspiratory pressure ≤ 28 cm H2O, with a maximum driving pressure ≤ 15 cm H2O, enabling tidal volumes between 4 and 8 ml/kg of predicted body weight (PBW)
- ECMO membrane sweep flow ≤ 2 L/min
- Patient protected by social security
Who cannot join
- Contraindication to the placement of an esophageal pressure balloon (e.g., esophageal varices, nasal trauma, uncontrolled coagulopathy, severe thrombocytopenia),
- Patient with treatment limitation at the time of inclusion,
- Patient in the time frame of exclusion from another research protocol at the time of consent signing,
- Vulnerable patients: minor, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Hospices Civiles de Lyon
Lyon
Jean-Christophe RICHARD, M.D, Ph.D, j-christophe.richard@chu-lyon.fr
- Recruiting
Assistance - Publique Hôpitaux de Marseille
Marseille, 13005
Sami HRAIECH, M.D, Ph.D., 04 91 96 58 35 ext. +33, sami.hraiech@ap-hm.fr
Christophe GUERVILLY, M.D., 04 91 96 58 35 ext. +33, christophe.guervilly@ap-hm.fr
- Recruiting
CHU de Nice
Nice
Denis DOYEN, M.D, doyen.d@chu-nice.fr
- Recruiting
Assistance Publique - Hôpitaux de Paris
Paris
Matthieu SCHMIDT, M.D, Ph.D, matthieu.schmidt@aphp.fr
About this study
Official title: Monitoring of Occlusion Pressure and Esophageal Pressure to Guide Weaning From Venovenous ECMO in ARDS: a Randomized Controlled Study
In its most severe form, Acute Respiratory Distress Syndrome (ARDS) may require the use of veno-venous ECMO (vvECMO). While the criteria for vvECMO indication, ECMO settings, and ventilator management are relatively well-defined after the publication of the EOLIA trial and subsequent national or international guidelines, few studies have assessed the criteria and methods for weaning from vvECMO. Besides, advances in the understanding of the pathophysiology of mechanical ventilation (MV) weaning process have led to the development of specific monitoring tools for this phase.
Schematically, respiratory drive can be evaluated via the ventilator by measuring the pressure generated during a 100-millisecond expiratory occlusion (P0.1) and respiratory efforts through the measurement of esophageal pressure variation (delta Poeso).
Read more
Recent retrospective studies conducted on COVID-19 ARDS patients supported by vvECMO suggest a longer duration of mechanical ventilation for patients whose weaning and decannulation process was "forced," i.e., performed under conditions of significant respiratory drive and effort. High values of P0.1 and delta Poeso were associated with prolonged MV duration. Self-inflicted lung injury (P-SILI) and elevated transpulmonary pressure related to these uncontrolled respiratory efforts likely explain the negative impact on MV duration.
Therefore, this randomized study proposes to assess these monitoring tools, which are regularly used in clinical practice, to guide vvECMO weaning and decannulation decisions.
- Being tested
- P0.1 and delta Poeso integration into the decanulation decision
- Keywords
- veno-venous ECMO, Decannulation
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P0.1 and delta Poeso integration into the decanulation decisionOther
P0.1 and delta Poeso integration into the decanulation decision
| Study group | Role | What they receive |
|---|---|---|
| ECMO-physio group | Experimental | Patients undergo the ultimate vvECMO weaning test with minimal ECMO support (ECMO flow ≤ 3 L/min, fresh gas flow ≤ 1 L/min, FiO2 21%) and mechanical ventilation with partial support, allowing spontaneous ventilation. P0.1 and delta Poeso values will be monitored and integrated into the decannulation decision Receives: Other: P0.1 and delta Poeso integration into the decanulation decision |
| ECMO-gazo group | No intervention | Patients undergo the ultimate vvECMO weaning test with minimal ECMO support, similar to the experimental group. P0.1 and delta Poeso values will be monitored in a blinded manner by an independent investigator and will not be integrated into the decannulation decision. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation from ECMO decannulation to weaning from mechanical ventilation
The weaning from mechanical ventilation is defined as the absence of mechanical ventilation for 48 consecutive hours.
Measured: 60 days after inclusion
P0.1 and delta Poeso measurements
P0.1 and delta Poeso values will be monitored and tracked at inclusion and then every 8 hours until decannulation, and up to 48 hours after decannulation.
In the experimental group, these values will be incorporated into the criteria guiding the decannulation decision.
In the control group, these values will be monitored and recorded by an investigator who is not involved in the decannulation decision. These values will not be included in the criteria guiding the decannulation decision.
Measured: From inclusion to 48h after decanulation
Secondary outcomes (17)
Mortality rate in intensive care unit
Measured: 60 days after inclusion
Mortality rate in hospital
Measured: 60 days after inclusion
Intensive care unit stay duration from inclusion
Measured: 60 days after inclusion
Hospital stay duration from inclusion
Measured: 60 days after inclusion
Total number of days spent on ECMO from admission to intensive care unit discharge
Measured: 60 days after inclusion
Total duration of mechanical ventilation
Measured: 60 days after inclusion
Time between the start of mechanical ventilation and ECMO cannulation
Measured: 60 days after inclusion
Number of ventilator-free days
Measured: 60 days after inclusion
Number of patients decannulated and then re-initiated on vvECMO
Measured: 60 days after inclusion
Number of patients requiring controlled ventilation for at least 24 hours after decannulation
Measured: 60 days after inclusion
Number of days with continuous sedation with or without continuous paralysis after decannulation
Measured: 60 days after inclusion
Incidence of barotrauma assessed by radiographs and clinical examination after decannulation
Measured: 60 days after inclusion
Percentage of patients placed in prone positioning after decannulation
Measured: 60 days after inclusion
Number of days on inhaled nitric oxide after decannulation
Measured: 60 days after inclusion
Neuromyopathy on the day of decannulation
Neuromyopathy will be assessed using the Medical Research Council score. Total score ranges from 0 (complete tetraplegia) to 60 (normal muscle strength).
Measured: Day of decanulation
Neuromyopathy on the day of weaning from mechanical ventilation
Neuromyopathy will be assessed using the Medical Research Council score. Total score ranges from 0 (complete tetraplegia) to 60 (normal muscle strength).
Measured: Day of weaning from mechanical ventilation
Number of patients who received corticosteroid therapy
≥ 0.5 mg/kg of equivalent methylprednisolone
Measured: 60 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start29 Jul 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, Assistance Publique - Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876415
- Sponsor's protocol ID
- RCAPHM23_0464
- Other IDs
- ID-RCB
- Acronym
- FORWARD
- Status last verified
- Nov 2025
- First submitted
- 10 Mar 2025
- Last updated
- 19 Nov 2025
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Occlusion Pressure and Esophageal Pressure to Guide Weaning From Venovenous ECMO in ARDS: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06876415
- Acronym / sponsor ID
- FORWARD / RCAPHM23_0464
- Keywords
- veno-venous ECMO, Decannulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 14 Mar 2025 (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.
In its most severe form, Acute Respiratory Distress Syndrome (ARDS) may require the use of veno-venous ECMO (vvECMO). While the criteria for vvECMO indication, ECMO settings, and ventilator management are relatively well-defined after the publication of the EOLIA trial and subsequent national or international guidelines, few studies have assessed the criteria and methods for weaning from vvECMO. Besides, advances in the understanding of the pathophysiology of mechanical ventilation (MV) weaning process have led to the development of specific monitoring tools for this phase.
Schematically, respiratory drive can be evaluated via the ventilator by measuring the pressure generated during a 100-millisecond expiratory occlusion (P0.1) and respiratory efforts through the measurement of esophageal pressure variation (delta Poeso).
Recent retrospective studies conducted on COVID-19 ARDS patients supported by vvECMO suggest a longer duration of mechanical ventilation for patients whose weaning and decannulation process was "forced," i.e., performed under conditions of significant respiratory drive and effort. High values of P0.1 and delta Poeso were associated with prolonged MV duration. Self-inflicted lung injury (P-SILI) and elevated transpulmonary pressure related to these uncontrolled respiratory efforts likely explain the negative impact on MV duration.
Therefore, this randomized study proposes to assess these monitoring tools, which are regularly used in clinical practice, to guide vvECMO weaning and decannulation decisions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECMO-physio group | Experimental | Other: P0.1 and delta Poeso integration into the decanulation decisionPatients undergo the ultimate vvECMO weaning test with minimal ECMO support (ECMO flow ≤ 3 L/min, fresh gas flow ≤ 1 L/min, FiO2 21%) and mechanical ventilation with partial support, allowing spontaneous ventilation. P0.1 and delta Poeso values will be monitored and integrated into the decannulation decision |
| ECMO-gazo group | No intervention | –Patients undergo the ultimate vvECMO weaning test with minimal ECMO support, similar to the experimental group. P0.1 and delta Poeso values will be monitored in a blinded manner by an independent investigator and will not be integrated into the decannulation decision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients aged 18 years or older Patient whose trusted person has given consent for participation in the study
- Patient on veno-venous ECMO with weaning criteria, including:
- Resolution of the cause of ARDS
- Absence of hemodynamic instability, defined as norepinephrine dose ≤ 0.5 μg/kg/min for at least 3 hours
- Use of a ventilatory mode that allows spontaneous ventilation (VS-AI, BiPAP, or APRV)
Key exclusion criteria (4 listed)
- Contraindication to the placement of an esophageal pressure balloon (e.g., esophageal varices, nasal trauma, uncontrolled coagulopathy, severe thrombocytopenia),
- Patient with treatment limitation at the time of inclusion,
- Patient in the time frame of exclusion from another research protocol at the time of consent signing,
- Vulnerable patients: minor, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman.
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 |
|---|---|---|
| P0.1 and delta Poeso integration into the decanulation decisionP0.1 and delta Poeso integration into the decanulation decision | Other | ECMO-physio group |
Primary outcome
Duration of mechanical ventilation from ECMO decannulation to weaning from mechanical ventilation
Time frame: 60 days after inclusion
The weaning from mechanical ventilation is defined as the absence of mechanical ventilation for 48 consecutive hours.
P0.1 and delta Poeso measurements
Time frame: From inclusion to 48h after decanulation
P0.1 and delta Poeso values will be monitored and tracked at inclusion and then every 8 hours until decannulation, and up to 48 hours after decannulation. In the experimental group, these values will be incorporated into the criteria guiding the decannulation decision. In the control group, these values will be monitored and recorded by an investigator who is not involved in the decannulation decision. These values will not be included in the criteria guiding the decannulation decision.
17 secondary outcomes
Mortality rate in intensive care unit
Time frame: 60 days after inclusion
Mortality rate in hospital
Time frame: 60 days after inclusion
Intensive care unit stay duration from inclusion
Time frame: 60 days after inclusion
Hospital stay duration from inclusion
Time frame: 60 days after inclusion
Total number of days spent on ECMO from admission to intensive care unit discharge
Time frame: 60 days after inclusion
Total duration of mechanical ventilation
Time frame: 60 days after inclusion
Time between the start of mechanical ventilation and ECMO cannulation
Time frame: 60 days after inclusion
Number of ventilator-free days
Time frame: 60 days after inclusion
Number of patients decannulated and then re-initiated on vvECMO
Time frame: 60 days after inclusion
Number of patients requiring controlled ventilation for at least 24 hours after decannulation
Time frame: 60 days after inclusion
Number of days with continuous sedation with or without continuous paralysis after decannulation
Time frame: 60 days after inclusion
Incidence of barotrauma assessed by radiographs and clinical examination after decannulation
Time frame: 60 days after inclusion
Percentage of patients placed in prone positioning after decannulation
Time frame: 60 days after inclusion
Number of days on inhaled nitric oxide after decannulation
Time frame: 60 days after inclusion
Neuromyopathy on the day of decannulation
Time frame: Day of decanulation
Neuromyopathy on the day of weaning from mechanical ventilation
Time frame: Day of weaning from mechanical ventilation
Number of patients who received corticosteroid therapy
Time frame: 60 days after inclusion
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 19 Nov 2025.
- 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.
François CREMIEUX study director
Assistance Publique - Hôpitaux de Marseille
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P0.1 and delta Poeso integration into the decanulation decision in people with ARDS (Acute Respiratory Distress Syndrome), run by Assistance Publique Hopitaux De Marseille at 4 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 8 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Sami HRAIECH, M.D., Ph.D (04 91 96 58 35 ext. +33, sami.hraiech@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of mechanical ventilation from ECMO decannulation to weaning from mechanical ventilation (time frame: 60 days after inclusion). The study lists 2 primary outcomes in all. 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 19 Nov 2025.