EVAPE: Evaluation of Practices of ECMO or ECLS and Ethical Implications in France

Sponsor
Centre Hospitalier La Chartreuse (Other)
Overall Status
Unknown status
CT.gov ID
NCT04188886
Collaborator
Elodie BERG (Other)
500
1
22
22.7

Study Details

Study Description

Brief 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 implementation and its medical and paramedical management. Everyone, with their knowledge and experience, has an opinion on the relevance of this therapy.

Condition or Disease Intervention/Treatment Phase
  • Other: Practice survey

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

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Evaluation of the Daily Practices of ECMO Veino-arterial and Their Ethical Implications in France: Multicenter Observational Study (Evaluation of Professional Practice)
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Oct 29, 2019
Anticipated Study Completion Date :
Dec 31, 2020

Outcome Measures

Primary Outcome Measures

  1. Evaluation the involvement of professionals in ECMO-related decisions [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

Secondary Outcome Measures

  1. Identification of the profession of each person involved in the management of the patients [1 day]

    Through an anonymous questionnaire, identifying the profession of each person involved in the management of the patients

  2. Demographic data (age, sexe) of each personnel involved in the management of the patients [1 day]

    Through an anonymous questionnaire, identifying the demographic data of the health care staff involved in the care management of the patients

  3. Level of training and knowledge of each personnel involved in the management of the patients [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

  4. Opinion of the health care staff on the care management of the patients [1 day]

    Through an anonymous questionnaire, clarify the opinion of health care staff on care management

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Bourgogne Franche Comté Dijon France 21000

Sponsors and Collaborators

  • Centre Hospitalier La Chartreuse
  • Elodie BERG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MORGANT Marie-Catherine, PI, Centre Hospitalier La Chartreuse
ClinicalTrials.gov Identifier:
NCT04188886
Other Study ID Numbers:
  • ElodieBERG2019
First Posted:
Dec 6, 2019
Last Update Posted:
Dec 6, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 6, 2019