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.

Study Overview

• Status: Unknown
• Conditions: Life Support Systems
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • CHU Bourgogne Franche Comté
    • Contact: Elodie BERG, MD; Phone Number: +33-380281294; Email: elodie.berg.eb@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All medical and paramedical personnel involved in decision making, installation, and monitoring of the ECMO

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation the involvement of professionals in ECMO-related decisions	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of the profession of each person involved in the management of the patients	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	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	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	Through an anonymous questionnaire, clarify the opinion of health care staff on care management	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier La Chartreuse
• Collaborators: Elodie BERG

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): October 29, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ElodieBERG2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will not be disclosed individually to other researchers. The analysis is done in a global way

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No