- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT04188886
Evaluation of Practices of ECMO or ECLS and Ethical Implications in France (EVAPE)
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.
Studie Overzicht
Gedetailleerde beschrijving
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)
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Dijon, Frankrijk, 21000
- Werving
- CHU Bourgogne Franche Comté
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Contact:
- Elodie BERG, MD
- Telefoonnummer: +33-380281294
- E-mail: elodie.berg.eb@gmail.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- All medical and paramedical personnel involved in decision making, installation, and monitoring of the ECMO
Exclusion Criteria:
- MEDICAL AND PARAMEDICAL STAFF NOT INVOLVED IN THE ESTABLISHMENT OR FOLLOW-UP OF THE ECMO
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Evaluation the involvement of professionals in ECMO-related decisions
Tijdsspanne: 1 day
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Through an anonymous questionnaire, the investigators will evaluate the speciality (eg cardiac surgeon, anesthesiologist...) of the doctor responsible for the indication of ECLS
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1 day
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Identification of the profession of each person involved in the management of the patients
Tijdsspanne: 1 day
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Through an anonymous questionnaire, identifying the profession of each person involved in the management of the patients
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1 day
|
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Demographic data (age, sexe) of each personnel involved in the management of the patients
Tijdsspanne: 1 day
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Through an anonymous questionnaire, identifying the demographic data of the health care staff involved in the care management of the patients
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1 day
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Level of training and knowledge of each personnel involved in the management of the patients
Tijdsspanne: 1 day
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Through an anonymous questionnaire, identifying the level of training and knowledge of the health care staff involved in the care management of the patients
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1 day
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Opinion of the health care staff on the care management of the patients
Tijdsspanne: 1 day
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Through an anonymous questionnaire, clarify the opinion of health care staff on care management
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1 day
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- ElodieBERG2019
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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