- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05146856
Impact of a Day Without Clinical Activity Before Night Shift on Non-technical Skills of Intensive Care Residents (REPOPREGARD)
Impact of a Modified Schedule Including a Day Without Clinical Activity Before Night Shift on Non-technical Skills of French Residents in Intensive Care Unit, a Prospective Randomized Multi Center Study: REPOPREGARD Protocol Study
In this proposal, investigators seek to address conclusively two knowledge gaps: 1) the lack of data on the impact of a schedule including a day off clinic before night shift on performances of residents in anesthesia or critical care medicine and 2) the lack of data on the relationship between resident sleep deprivation and their non technical skills impairment. Investigators designed a prospective, randomized, blinded in cross over evaluation of medical pratices. Investigators will compare resident's performance during a high fidelity simulation session, on crisis managment in intensive care unit, after a night shift in intensive care unit, of residents who work on an intervention schedule with no clinical activity before night shift, with resident's performance of residents who had a traditionnal schedule including an usual clinical day before night shift. Investigators also assess cognitive performances, sleepiness and self esteem before and after night shift. Investigators specific aims will be:
To test the hypothesis that residents working on an intervention schedule will have non technical skills, assessed by Ottawa GRS global score, significantly less impaired after a night shift, than those on traditionnal schedule
To test the hypothesis that residents working on an interveniton schedule will have cognitive performances, sleepiness and self esteem less impaired after night shift than those on a traditionnal schedule
연구 개요
상태
정황
상세 설명
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Clermont-Ferrand, 프랑스, 63000
- Clermont-Ferrand University Hospital
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수석 연구원:
- Alexandre LAUTRETTE
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- residents in Anesthesia or Critical care medicine
- Who effect night shift in intensive care unit
- Able to take a day off clinic before night shift
- Able to give consent
Exclusion Criteria:
- Refusal of participation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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Control
Residents in control group have a usual day with clinical activity before night shift
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Intervention
Residents in intervention group have a day off clinic before night shift (i.e day off or day with university activity)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Residents' non technical skills after a night shift
기간: Immediatly after the end of the night shift
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Measured by Ottawa Global Rated Scale global score assessed during a high fidelity simulation session of crisis managment.
Global score is comprise between 7 for a performance expected from a beginner and 42 for a performance expeted from an expert.
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Immediatly after the end of the night shift
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Residents' non technical skill before a night shift
기간: Baseline, before the night shift
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Measured by Ottawa Global Rated Scale global score assessed during a high fidelity simulation session of crisis managment.
Global score is comprise between 7 for a performance expected from a beginner and 42 for a performance expeted from an expert.
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Baseline, before the night shift
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Cognitive performances : Phasic alert test
기간: Before the night shift
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refers to the notion of general wakefulness allowing to react quickly and appropriately to requests, score obtained from computer tool
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Before the night shift
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Cognitive performances : Phasic alert test
기간: After the night shift up to 12 hours
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refers to the notion of general wakefulness allowing to react quickly and appropriately to requests, score obtained from computer tool
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After the night shift up to 12 hours
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Cognitive performances : Divided attention test
기간: Before the night shift
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refers to the notion of paying attention to several things at the same time, score obtained from computer tool
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Before the night shift
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Cognitive performances : Divided attention test
기간: After the night shift up to 12 hours
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refers to the notion of paying attention to several things at the same time, score obtained from computer tool
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After the night shift up to 12 hours
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Cognitive performances : Flexibility test with alternation
기간: Before the night shift
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refers to the notion of displacement of the attentional focus, score obtained from computer tool
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Before the night shift
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Cognitive performances : Flexibility test with alternation
기간: After the night shift up to 12 hours
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refers to the notion of displacement of the attentional focus, score obtained from computer tool
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After the night shift up to 12 hours
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Cognitive performances : Working memory test
기간: Before the night shift
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refers to the notion of maintaining and updating when carrying out complex problems, score obtained from computer tool
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Before the night shift
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Cognitive performances : Working memory test
기간: After the night shift up to 12 hours
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refers to the notion of maintaining and updating when carrying out complex problems, score obtained from computer tool
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After the night shift up to 12 hours
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Cognitive performances : Computerized Speed Cognitive Test
기간: Before the night shift
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refers to the notion of the speed of information processing, score obtained from computer tool
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Before the night shift
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Cognitive performances : Computerized Speed Cognitive Test
기간: After the night shift up to 12 hours
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refers to the notion of the speed of information processing, score obtained from computer tool
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After the night shift up to 12 hours
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Sleepiness
기간: Before the night shift
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Measured by Karolinska Sleepiness scale, a score of 1 for a great tiredness to 9 for a very well awake state.
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Before the night shift
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Sleepiness
기간: After the night shift up to 12 hours
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Measured by Karolinska Sleepiness scale, a score of 1 for a great tiredness to 9 for a very well awake state.
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After the night shift up to 12 hours
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Self esteem
기간: Before the night shift
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Measured by Rosenberg Self Esteem scale, a score lower than 25 indicates a low self esteem and a score higher than 39 indicates a high self esteem.
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Before the night shift
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Self esteem
기간: After the night shift up to 12 hours
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Measured by Rosenberg Self Esteem scale, a score lower than 25 indicates a low self esteem and a score higher than 39 indicates a high self esteem.
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After the night shift up to 12 hours
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2021 LAUTRETTE REPOPREGARDE
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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