- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Warunki
Szczegółowy opis
Typ studiów
Zapisy (Oczekiwany)
Kontakty i lokalizacje
Lokalizacje studiów
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Clermont-Ferrand, Francja, 63000
- Clermont-Ferrand University Hospital
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Główny śledczy:
- Alexandre LAUTRETTE
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Residents' non technical skills after a night shift
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Residents' non technical skill before a night shift
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Oczekiwany)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2021 LAUTRETTE REPOPREGARDE
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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