- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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)
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
-
-
Dijon, 프랑스, 21000
- 모병
- CHU Bourgogne Franche Comté
-
연락하다:
- Elodie BERG, MD
- 전화번호: +33-380281294
- 이메일: elodie.berg.eb@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Evaluation the involvement of professionals in ECMO-related decisions
기간: 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
|
1 day
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Identification of the profession of each person involved in the management of the patients
기간: 1 day
|
Through an anonymous questionnaire, identifying the profession of each person involved in the management of the patients
|
1 day
|
|
Demographic data (age, sexe) of each personnel involved in the management of the patients
기간: 1 day
|
Through an anonymous questionnaire, identifying the demographic data of the health care staff involved in the care management of the patients
|
1 day
|
|
Level of training and knowledge of each personnel involved in the management of the patients
기간: 1 day
|
Through an anonymous questionnaire, identifying the level of training and knowledge of the health care staff involved in the care management of the patients
|
1 day
|
|
Opinion of the health care staff on the care management of the patients
기간: 1 day
|
Through an anonymous questionnaire, clarify the opinion of health care staff on care management
|
1 day
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- ElodieBERG2019
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .