Respiratory Distress SyndromeDD-ECMONCT04613752
Diaphragm Dysfunction in ARDS Patients With V-V ECMO
A study testing diaphragmatic function measurements and diaphragmatic ultrasound in people with Respiratory Distress Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Use of veno-venous extracorporeal oxygenation membrane is a therapeutic option for the management of the most severe patients with acute respiratory distress syndrome (ARDS). Given the prolonged duration of this strategy, the question of its impact on the occurrence on diaphragm dysfunction has been raised. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- diaphragmatic function measurements and diaphragmatic ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2021to 15 Oct 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
- ARDS according to the Berlin definition
- V-V ECMO
- patient or next of kin agrees to participate
- patient with health insurance
Who cannot join
- pregnancy
- Opposition to participate
- Contra indications to the phrenic nerves stimulation technique (pace maker, pneumothorax)"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation and Follow up of Diaphragm Function in Acute Respiratory Distress Syndrome Patients With Veino-venous Extracorporeal Oxygenation Membrane
Use of veno-venous extracorporeal oxygenation membrane is a therapeutic option for the management of the most severe patients with acute respiratory distress syndrome (ARDS).
Given the prolonged duration of this strategy, the question of its impact on the occurrence on diaphragm dysfunction has been raised. The present study endeavors to evaluate and follow up the prevalence, risk factors and prognosis of diaphragm dysfunction in patients with VV-ECMO.
Read the detailed description
Use of veno-venous extracorporeal oxygenation membrane is a therapeutic option for the management of the most severe patients with acute respiratory distress syndrome (ARDS). It allows to provide a protective lung ventilation by reducing the level of airway pressures generated by the ventilator. The objective is to minimize the harmful effects of mechanical ventilation in the lungs and to provide adequate gases exchanges. This strategy requires a deep sedation to allow a perfect synchrony between the patient and the ventilator. Such a synchrony puts the respiratory muscles - in particular the diaphragm - completely at rest.
Given the prolonged duration of this strategy, the question of its impact on the occurrence on diaphragm dysfunction has been raised. Such a dysfunction has been associated with prolonged duration of mechanical ventilation and poor outcomes but its effect in patients with veno-venous extracorporeal oxygenation membrane has never been evaluated so far.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- diaphragmatic function measurements and diaphragmatic ultrasound
- Keywords
- ARDS, ECMO, diaphragm function
- 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.
diaphragmatic function measurements and diaphragmatic ultrasoundDevice
A single experimental group in which diaphragmatic function measurements and diaphragmatic ultrasound will be performed.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | A single experimental group in which diaphragmatic function measurements and diaphragmatic ultrasound will be performed. Receives: Device: diaphragmatic function measurements and diaphragmatic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm function
as defined by the pressure generating capacity of the diaphragm < 11 cmH2O
Measured: until day 28
Secondary outcomes (2)
Duration of ECMO
from inclusion until ECMO removal
Measured: until day 60
Duration of invasive mechanical ventilation
from inclusion until extubation
Measured: until day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start15 Feb 2021
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Why it stopped: No more Covid patients in the service and number of patients included sufficient for stastistical analysis.
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 Respiratory Distress SyndromeStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Dres, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613752
- Sponsor's protocol ID
- APHP190988
- Acronym
- DD-ECMO
- Status last verified
- May 2022
- First submitted
- 15 Oct 2020
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gautier M, Joussellin V, Ropers J, El Houari L, Demoule A, Similowski T, Combes A, Schmidt M, Dres M. Diaphragm function in patients with Covid-19-related acute respiratory distress syndrome on venovenous extracorporeal membrane oxygenation. Ann Intensive Care. 2023 Sep 26;13(1):92. doi: 10.1186/s13613-023-01179-w.
PubMed 37752337
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Follow up of Diaphragm Function in Acute Respiratory Distress Syndrome Patients With Veino-venous Extracorporeal Oxygenation Membrane
- ClinicalTrials.gov ID
- NCT04613752
- Acronym / sponsor ID
- DD-ECMO / APHP190988
- Conditions
- Respiratory Distress Syndrome
- Keywords
- ARDS, ECMO, diaphragm function
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No more Covid patients in the service and number of patients included sufficient for stastistical analysis.
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 3 Nov 2020 (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.
Use of veno-venous extracorporeal oxygenation membrane is a therapeutic option for the management of the most severe patients with acute respiratory distress syndrome (ARDS).
Given the prolonged duration of this strategy, the question of its impact on the occurrence on diaphragm dysfunction has been raised. The present study endeavors to evaluate and follow up the prevalence, risk factors and prognosis of diaphragm dysfunction in patients with VV-ECMO.
Detailed description
Use of veno-venous extracorporeal oxygenation membrane is a therapeutic option for the management of the most severe patients with acute respiratory distress syndrome (ARDS). It allows to provide a protective lung ventilation by reducing the level of airway pressures generated by the ventilator. The objective is to minimize the harmful effects of mechanical ventilation in the lungs and to provide adequate gases exchanges. This strategy requires a deep sedation to allow a perfect synchrony between the patient and the ventilator. Such a synchrony puts the respiratory muscles - in particular the diaphragm - completely at rest.
Given the prolonged duration of this strategy, the question of its impact on the occurrence on diaphragm dysfunction has been raised. Such a dysfunction has been associated with prolonged duration of mechanical ventilation and poor outcomes but its effect in patients with veno-venous extracorporeal oxygenation membrane has never been evaluated so far.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: diaphragmatic function measurements and diaphragmatic ultrasoundA single experimental group in which diaphragmatic function measurements and diaphragmatic ultrasound will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 18 years
- ARDS according to the Berlin definition
- V-V ECMO
- patient or next of kin agrees to participate
- patient with health insurance
Key exclusion criteria (3 listed)
- pregnancy
- Opposition to participate
- Contra indications to the phrenic nerves stimulation technique (pace maker, 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 |
|---|---|---|
| diaphragmatic function measurements and diaphragmatic ultrasoundA single experimental group in which diaphragmatic function measurements and diaphragmatic ultrasound will be performed. | Device | experimental group |
Primary outcome
Diaphragm function
Time frame: until day 28
as defined by the pressure generating capacity of the diaphragm < 11 cmH2O
2 secondary outcomes
Duration of ECMO
Time frame: until day 60
Duration of invasive mechanical ventilation
Time frame: until day 60
Results and safety
The study was stopped early (reason given: No more Covid patients in the service and number of patients included sufficient for stastistical analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Derived from this study: PubMed 37752337Gautier M, Joussellin V, Ropers J, El Houari L, Demoule A, Similowski T, Combes A, Schmidt M, Dres M. Diaphragm function in patients with Covid-19-related acute respiratory distress syndrome on venovenous extracorporeal membrane oxygenation. Ann Intensive Care. 2023 Sep 26;13(1):92. doi: 10.1186/s13613-023-01179-w.
- 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.
Martin Dres study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diaphragmatic function measurements and diaphragmatic ultrasound in people with Respiratory Distress Syndrome, run by Assistance Publique - Hôpitaux de Paris 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 5 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: stopped early, as of the sponsor's last update on 15 Jun 2022. 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 was stopped early (reason given: No more Covid patients in the service and number of patients included sufficient for stastistical analysis.). Results are not available in the source record.
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?
Diaphragm function (time frame: until day 28). 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 NCT04613752, 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 15 Jun 2022.