- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Detaljerad beskrivning
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)
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Dijon, Frankrike, 21000
- Rekrytering
- CHU Bourgogne Franche Comté
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Kontakt:
- Elodie BERG, MD
- Telefonnummer: +33-380281294
- E-post: elodie.berg.eb@gmail.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Evaluation the involvement of professionals in ECMO-related decisions
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Identification of the profession of each person involved in the management of the patients
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- ElodieBERG2019
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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