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

NCT ID: NCT04188886

Last Updated: 2019-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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)

Conditions

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Life Support Systems

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Practice survey

Practice survey on

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Elodie BERG

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier La Chartreuse

OTHER

Sponsor Role lead

Responsible Party

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MORGANT Marie-Catherine

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHU Bourgogne Franche Comté

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Aline LAUBRIET JAZAYERI, PhD

Role: CONTACT

Phone: +33-380281294

Email: [email protected]

Facility Contacts

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Elodie BERG, MD

Role: primary

Other Identifiers

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ElodieBERG2019

Identifier Type: -

Identifier Source: org_study_id