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

• Conditions: Life Support Systems

• Registration Number: NCT04188886
• Lead Sponsor: Centre Hospitalier La Chartreuse

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.

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 Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-10-29
• Study First Submitted: 2019-10-29
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-05
• Last Update Submitted: 2019-12-05
• Study First Posted: 2019-12-06
• Last Update Posted: 2019-12-06
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

CHU Bourgogne Franche Comté; 🇫🇷 Dijon, France