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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04578054
Other study ID # 2020 BOUILLON MINOIS Fly Micu
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date July 1, 2025

Study information

Verified date October 2020
Source University Hospital, Clermont-Ferrand
Contact Lise LACLAUTRE
Phone 0473751195
Email promo_interne_drci@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patient care who requires fast and intensive care by a mobile intensive care unit in a rescue helicopter is a common practice in Auvergne since more than 3 years. Indeed, a complete team (nurse and emergency physician) is on Dragon 63 and HeliSMUR 63 (SMUR = emergency medical services ). There are multiple fields of action, with a primary rescue activity (patient care directly at the site of the operation) but also secondary transport (transfer of patients from one hospital to another). This allows a reduction in transport time and therefore unavailability of the MICU team in general hospitals, which are in short supply of attending physicians. In addition, this allows patients to be repatriated to the Clermont-Ferrand University Hospital Center, which is the reference center for many pathologies and has the Level 3 adult and pediatric Trauma Center.


Description:

This is an observational study using a REDCap® questionnaire via an internet link, which will be distributed by any means (institution mailing lists via a referent, flash codes distributed to physicians, etc.).

The questionnaire will assess the type of medicalisation, the type of activity, the different hours of intervention, the age, the type and the severity of the patient's disease, the type of care practiced and the stress of the physician.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date July 1, 2025
Est. primary completion date July 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Every Emergency Physician that participate to the Helicopter rescue

Exclusion Criteria:

- Every Emergency Physician non-voluntary to participate

Study Design


Intervention

Other:
Flying transport
Patient care who requires flying transport

Locations

Country Name City State
France Clermont-Ferrand University Hospital Clermont-Ferrand

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand Faculty of Medicine and Paramedical Professions, Clermont-Ferrand, France, UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stress stress level will be assessed by Visual Analog Scale (VAS) from 0 to 10 (0 the lowest stress and 10 the highest) Day 1
Secondary Severity of the disease Severity of the disease that need MICU team for the care measure by Classification Clinique des Malades aux Urgence CCMU scale (1 to 5 ; 1 is the lowest problem and 5 the severest ; + P : Psychiatric + D : death at the arrival, no reanimation) Day 1
Secondary Duration of the care Every schedules of the care : departure from Clermont-Ferrand University Hospital, arrival at the victim, departure from the accident or take care place, arrival at Clermont-Ferrand university hospital, time of the patient transmission, time of disponibility Day 1
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