IntensivistAMACNCT04567017
Physical Activity of Staff on Medical Duty in a Department of Anesthesia and Critical Care During Guards
An observational study of Intensivist and Resident, run by CHU de Reims at 1 site in France.
Trial summary
On-call work is an integral part of senior and junior patricians in a critical care department. Several studies have examined the effect of sleep deprivation on physicians on call and the impact of sleep deprivation on the quality of patient care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intensivist, Resident, Night Work
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 1 Oct 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: voluntary practitioners and residents of the critical care department (intensive care, emergencies and anaesthesia)
Who may be able to join
- voluntary practitioners and residents of the critical care department (intensive care, emergencies and anaesthesia)
Who cannot join
- refusal to participate
- musculoskeletal disorders
- a significant medical history that prevents normal physical activity for age
Trial locations and contacts
1 site in 1 country.
France1 site
Damien JOLLY
Reims
Vincent LEGROS, 03 26 78 30 21, vlegros@chu-reims.fr
About this study
On-call work is an integral part of senior and junior patricians in a critical care department.
Several studies have examined the effect of sleep deprivation on physicians on call and the impact of sleep deprivation on the quality of patient care.
Read more
Some of these studies have shown that practitioners' concentration capacities have deteriorated as the guard progresses.
However, few studies have looked at the physical activity of practitioners over a period of on-call time (distance covered, number of steps,...), as well as other parameters than the time spent in communication over the telephone.
The age and seniority of practitioners seem to be factors that can influence these different parameters, and there are few figures in the literature.
Read the detailed description
Practitioners and juniors will be informed of the study. If they agree to participate in the study, each volunteer will receive an assessment of their cognitive functions before taking up their duties via the Montréal Cognitive Assessment (MOCA) version 7.1.
The place of exercise (emergencies, anaesthesia and ICU Each participant will be equipped with a connected watch with pedometer and cardiofrequencemeter function (Fitness Tracker F07Max).
During his on-call period a questionnaire will be given to him, with socio-demographic data, sleep duration and quality and the number of acts during the on-call period.
The telephone data will be analysed by querying the internal telephone system of the Reims University Hospital.
At the end of the on-call period, the analysis of the data from the connected watch will be analyzed and each volunteer will benefit from an evaluation of his cognitive functions via the Montreal Cognitive Assessment (MOCA) version 7.3 after taking up his duties.
Data will be collected during 2 shifts for each practitioner and junior
- Conditions
- Intensivist, Resident, Night Work
- Keywords
- Physical activity, guards, Intensive care
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of physical activity in physician according to seniority
mean distance in meter according to seniority
Measured: Day 1
Secondary outcomes (4)
measurement of physical activity in physician
mean distance in meter
Measured: Day 1
measurement of attention function
score in Birckenkamp D2-R test
Measured: Day 1
sleep duration
average sleep time
Measured: Day 1
quality of sleep
mean score on Spiegel scale
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 posted28 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntensivistStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567017
- Sponsor's protocol ID
- PO19103
- Acronym
- AMAC
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity of Staff on Medical Duty in a Department of Anesthesia and Critical Care During Guards
- ClinicalTrials.gov ID
- NCT04567017
- Acronym / sponsor ID
- AMAC / PO19103
- Conditions
- Intensivist, Resident, Night Work
- Keywords
- Physical activity, guards, Intensive care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 28 Sep 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.
On-call work is an integral part of senior and junior patricians in a critical care department.
Several studies have examined the effect of sleep deprivation on physicians on call and the impact of sleep deprivation on the quality of patient care.
Some of these studies have shown that practitioners' concentration capacities have deteriorated as the guard progresses.
However, few studies have looked at the physical activity of practitioners over a period of on-call time (distance covered, number of steps,...), as well as other parameters than the time spent in communication over the telephone.
The age and seniority of practitioners seem to be factors that can influence these different parameters, and there are few figures in the literature.
Detailed description
Practitioners and juniors will be informed of the study. If they agree to participate in the study, each volunteer will receive an assessment of their cognitive functions before taking up their duties via the Montréal Cognitive Assessment (MOCA) version 7.1.
The place of exercise (emergencies, anaesthesia and ICU Each participant will be equipped with a connected watch with pedometer and cardiofrequencemeter function (Fitness Tracker F07Max).
During his on-call period a questionnaire will be given to him, with socio-demographic data, sleep duration and quality and the number of acts during the on-call period.
The telephone data will be analysed by querying the internal telephone system of the Reims University Hospital.
At the end of the on-call period, the analysis of the data from the connected watch will be analyzed and each volunteer will benefit from an evaluation of his cognitive functions via the Montreal Cognitive Assessment (MOCA) version 7.3 after taking up his duties.
Data will be collected during 2 shifts for each practitioner and junior
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- voluntary practitioners and residents of the critical care department (intensive care, emergencies and anaesthesia)
Key inclusion criteria (1 listed)
- voluntary practitioners and residents of the critical care department (intensive care, emergencies and anaesthesia)
Key exclusion criteria (3 listed)
- refusal to participate
- musculoskeletal disorders
- a significant medical history that prevents normal physical activity for age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
measurement of physical activity in physician according to seniority
Time frame: Day 1
mean distance in meter according to seniority
4 secondary outcomes
measurement of physical activity in physician
Time frame: Day 1
measurement of attention function
Time frame: Day 1
sleep duration
Time frame: Day 1
quality of sleep
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 28 Sep 2020.
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Post Intensive Care Syndrome (PICS)
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 Intensivist and Resident, run by CHU de Reims 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 3 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 28 Sep 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 Vincent LEGROS (03 26 78 30 21, vlegros@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of physical activity in physician according to seniority (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 28 Sep 2020.