Stress, PsychologicalFLY-MICUNCT04578054
Benefit of the FLYing Transport of Patients Requiring Mobile Intensive Care Unit
An observational study of Stress, Psychological and Emergency Medicine, Transport, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 ). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Emergency Medicine, Transport, Critical Care
- What is being tested?
- Flying transport
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Emergency Physician
Who may be able to join
- Every Emergency Physician that participate to the Helicopter rescue
Who cannot join
- Every Emergency Physician non-voluntary to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clermont-Ferrand University Hospital
Clermont-Ferrand, 63000
Lise Laclau, 0473751195, promo_interne_drci@chu-clermontferrand.fr
Jean-Baptiste BOUILLON-MINOIS
About this study
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.
Read the detailed 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.
- Being tested
- Flying transport
- Keywords
- Stress, Psychological, emergency Medicine, transport, critical care
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flying transportOther
Patient care who requires flying transport
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
stress level will be assessed by Visual Analog Scale (VAS) from 0 to 10 (0 the lowest stress and 10 the highest)
Measured: Day 1
Secondary outcomes (2)
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)
Measured: Day 1
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Jul 2020
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578054
- Sponsor's protocol ID
- 2020 BOUILLON MINOIS Fly Micu
- Acronym
- FLY-MICU
- Status last verified
- Oct 2020
- First submitted
- 1 Oct 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of the FLYing Transport of Patients Requiring Mobile Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04578054
- Acronym / sponsor ID
- FLY-MICU / 2020 BOUILLON MINOIS Fly Micu
- Keywords
- Stress, Psychological, emergency Medicine, transport, critical care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Emergency Physician
Key inclusion criteria (1 listed)
- Every Emergency Physician that participate to the Helicopter rescue
Key exclusion criteria (1 listed)
- Every Emergency Physician non-voluntary to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flying transportPatient care who requires flying transport | Other | – |
Primary outcome
Stress
Time frame: Day 1
stress level will be assessed by Visual Analog Scale (VAS) from 0 to 10 (0 the lowest stress and 10 the highest)
2 secondary outcomes
Severity of the disease
Time frame: Day 1
Duration of the care
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, Psychological and Emergency Medicine, Transport, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (0473751195, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.