Life Support SystemsEVAPENCT04188886
Evaluation of Practices of ECMO or ECLS and Ethical Implications in France
An observational study of Life Support Systems, run by Centre Hospitalier La Chartreuse at 1 site in France.
Trial summary
Short-term circulatory support (ECMO/ECLS) has become a common emergency resuscitation support. Currently, the indication of the ECMO/ECLS relies more on clinic, biological and imagery arguments than on a real consensus.During the care of a patient under ECMO/ECLS, various stakeholders are involved in the… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Life Support Systems
- What is being tested?
- Practice survey
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 31 Dec 2020
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All medical and paramedical personnel involved in decision making, installation, and monitoring of the ECMO
Who may be able to join
- All medical and paramedical personnel involved in decision making, installation, and monitoring of the ECMO
Who cannot join
- MEDICAL AND PARAMEDICAL STAFF NOT INVOLVED IN THE ESTABLISHMENT OR FOLLOW-UP OF THE ECMO
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Bourgogne Franche Comté
Dijon, 21000
Elodie BERG, MD, +33-380281294, elodie.berg.eb@gmail.com
About this study
Official title: Evaluation of the Daily Practices of ECMO Veino-arterial and Their Ethical Implications in France: Multicenter Observational Study (Evaluation of Professional Practice)
Short-term circulatory support (ECMO/ECLS) has become a common emergency resuscitation support.
Currently, the indication of the ECMO/ECLS relies more on clinic, biological and imagery arguments than on a real consensus.During the care of a patient under ECMO/ECLS, various stakeholders are involved in the implementation and its medical and paramedical management. Everyone, with their knowledge and experience, has an opinion on the relevance of this therapy.
Read the detailed description
A validated questionnaire, translated from an Anglo-Saxon study, will be used as a basis for work and adapted. After the publication of a memo, it is accessible anonymously on a platform (ASKABOX) whose link is distributed by email by the secretaries or nursing staff. The city and the exercise service will be requested in the preamble of the questionnaire. It is composed of six demographic questions: age, gender, occupation, participation in emergency care, number of ECMOs encountered, level of knowledge about ECMO. The other questions concern concrete ECMO situations and the answers are nuanced from definitely yes to definitely no to allow professionals to express their opinion as well as possible. The targeted professionals are all those involved in the management of patients on ECMO: emergency physicians, anesthesiologists, surgeons, perfusionists, nurses, orderlies, ASHs.
A monocentric feasibility study was carried out with satisfactory results in terms of participation.
AN INFORMATION NOTE WILL BE ATTACHED WITH THE EMAIL AND THE LINK FOR THE QUESTIONNAIRE (ANONYMOUS)
- Conditions
- Life Support Systems
- Being tested
- Practice survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice surveyOther
Practice survey on
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the involvement of professionals in ECMO-related decisions
Through an anonymous questionnaire, the investigators will evaluate the speciality (eg cardiac surgeon, anesthesiologist...) of the doctor responsible for the indication of ECLS
Measured: 1 day
Secondary outcomes (4)
Identification of the profession of each person involved in the management of the patients
Through an anonymous questionnaire, identifying the profession of each person involved in the management of the patients
Measured: 1 day
Demographic data (age, sexe) of each personnel involved in the management of the patients
Through an anonymous questionnaire, identifying the demographic data of the health care staff involved in the care management of the patients
Measured: 1 day
Level of training and knowledge of each personnel involved in the management of the patients
Through an anonymous questionnaire, identifying the level of training and knowledge of the health care staff involved in the care management of the patients
Measured: 1 day
Opinion of the health care staff on the care management of the patients
Through an anonymous questionnaire, clarify the opinion of health care staff on care management
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start1 Mar 2019
- Primary completion29 Oct 2019
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Life Support SystemsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier La Chartreuse
- Sponsor type
- University, hospital or other
- Collaborators
- Elodie BERG
- Responsible party
- Principal investigator, MORGANT Marie-Catherine, Centre Hospitalier La Chartreuse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188886
- Sponsor's protocol ID
- ElodieBERG2019
- Acronym
- EVAPE
- Status last verified
- Dec 2019
- First submitted
- 29 Oct 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be disclosed individually to other researchers. The analysis is done in a global way
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Daily Practices of ECMO Veino-arterial and Their Ethical Implications in France: Multicenter Observational Study (Evaluation of Professional Practice)
- ClinicalTrials.gov ID
- NCT04188886
- Acronym / sponsor ID
- EVAPE / ElodieBERG2019
- Conditions
- Life Support Systems
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre Hospitalier La ChartreuseUniversity, hospital or other
- Collaborators
- Elodie BERG
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 6 Dec 2019 (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.
Short-term circulatory support (ECMO/ECLS) has become a common emergency resuscitation support.
Currently, the indication of the ECMO/ECLS relies more on clinic, biological and imagery arguments than on a real consensus.During the care of a patient under ECMO/ECLS, various stakeholders are involved in the implementation and its medical and paramedical management. Everyone, with their knowledge and experience, has an opinion on the relevance of this therapy.
Detailed description
A validated questionnaire, translated from an Anglo-Saxon study, will be used as a basis for work and adapted. After the publication of a memo, it is accessible anonymously on a platform (ASKABOX) whose link is distributed by email by the secretaries or nursing staff. The city and the exercise service will be requested in the preamble of the questionnaire. It is composed of six demographic questions: age, gender, occupation, participation in emergency care, number of ECMOs encountered, level of knowledge about ECMO. The other questions concern concrete ECMO situations and the answers are nuanced from definitely yes to definitely no to allow professionals to express their opinion as well as possible. The targeted professionals are all those involved in the management of patients on ECMO: emergency physicians, anesthesiologists, surgeons, perfusionists, nurses, orderlies, ASHs.
A monocentric feasibility study was carried out with satisfactory results in terms of participation.
AN INFORMATION NOTE WILL BE ATTACHED WITH THE EMAIL AND THE LINK FOR THE QUESTIONNAIRE (ANONYMOUS)
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All medical and paramedical personnel involved in decision making, installation, and monitoring of the ECMO
Key inclusion criteria (1 listed)
- All medical and paramedical personnel involved in decision making, installation, and monitoring of the ECMO
Key exclusion criteria (1 listed)
- MEDICAL AND PARAMEDICAL STAFF NOT INVOLVED IN THE ESTABLISHMENT OR FOLLOW-UP OF THE ECMO
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 |
|---|---|---|
| Practice surveyPractice survey on | Other | – |
Primary outcome
Evaluation the involvement of professionals in ECMO-related decisions
Time frame: 1 day
Through an anonymous questionnaire, the investigators will evaluate the speciality (eg cardiac surgeon, anesthesiologist...) of the doctor responsible for the indication of ECLS
4 secondary outcomes
Identification of the profession of each person involved in the management of the patients
Time frame: 1 day
Demographic data (age, sexe) of each personnel involved in the management of the patients
Time frame: 1 day
Level of training and knowledge of each personnel involved in the management of the patients
Time frame: 1 day
Opinion of the health care staff on the care management of the patients
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Individual participant dataSharing planned: No. The data will not be disclosed individually to other researchers. The analysis is done in a global way
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Life Support Systems, run by Centre Hospitalier La Chartreuse 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 1 inclusion and 1 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 6 Dec 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 Aline LAUBRIET JAZAYERI, PhD (+33-380281294, aline.laubriet@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the involvement of professionals in ECMO-related decisions (time frame: 1 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 6 Dec 2019.