Clinical trial NCT04188886: Evaluation of Practices of ECMO or ECLS and Ethical Implications in France
Official title: Evaluation of the Daily Practices of ECMO Veino-arterial and Their Ethical Implications in France: Multicenter Observational Study (Evaluation of Professional Practice)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Life Support Systems
Lead sponsor: Centre Hospitalier La Chartreuse
Sponsor class: OTHER
Collaborators: name: Elodie BERG
First posted: 2019-12-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All medical and paramedical personnel involved in decision making, installation, and monitoring of the ECMO

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)

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation the involvement of professionals in ECMO-related decisions
timeFrame: 1 day
Secondary outcomes:
measure: Identification of the profession of each person involved in the management of the patients
timeFrame: 1 day
measure: Demographic data (age, sexe) of each personnel involved in the management of the patients
timeFrame: 1 day
measure: Level of training and knowledge of each personnel involved in the management of the patients
timeFrame: 1 day
measure: Opinion of the health care staff on the care management of the patients
timeFrame: 1 day
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Bourgogne Franche Comté
Study officials:
References: