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Impact of a Day Without Clinical Activity Before Night Shift on Non-technical Skills of Intensive Care Residents (REPOPREGARD)

23. november 2021 opdateret af: University Hospital, Clermont-Ferrand

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

Main objective of this study is to compare the non-technical skills after night shift, of anaesthesia and critical care residents who did not have clinical activity before the night shift with those who had at least 8 hours of clinical activity before. The workforce is constrained by the number of residents in training at Clermont-Ferrand and Lyon University Public Hospital. Thus, it is possible to consider the inclusion of 60 residents for 55 evaluable. With such numbers, the clinically relevant difference of 6 points for the Ottawa GRS score (for a standard deviation of 11) can be demonstrated with an alpha risk of bilateral error of 5% and a power of 80%. Two interim analyzes will be carried out including the first 20 interns and then 20 additional interns (therefore for 40 interns) with the aim of stopping the study for "effectiveness", more precisely stopping the study for evidence of a statistically significant difference for the primary outcome measure, with risks of first error observed respectively at 0.0005 and 0.014 comparisons (correction due to multiples). A simulation of the statistical power will also be proposed during the performance of these analyzes; if necessary, a new estimation of the workforce will be proposed to the competent authorities. Investigators do not plan loss of follow up.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Clermont-Ferrand, Frankrig, 63000
        • Clermont-Ferrand University Hospital
        • Ledende efterforsker:
          • Alexandre LAUTRETTE

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The investigators will include volunteer residents in anesthesia of critical care medicine of Gabriel Montpied university hospital of Clermont Ferrand.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Control
Residents in control group have a usual day with clinical activity before night shift
Intervention
Residents in intervention group have a day off clinic before night shift (i.e day off or day with university activity)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Residents' non technical skills after a night shift
Tidsramme: Immediatly after the end of the night shift
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.
Immediatly after the end of the night shift

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Residents' non technical skill before a night shift
Tidsramme: Baseline, before the night shift
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.
Baseline, before the night shift
Cognitive performances : Phasic alert test
Tidsramme: Before the night shift
refers to the notion of general wakefulness allowing to react quickly and appropriately to requests, score obtained from computer tool
Before the night shift
Cognitive performances : Phasic alert test
Tidsramme: After the night shift up to 12 hours
refers to the notion of general wakefulness allowing to react quickly and appropriately to requests, score obtained from computer tool
After the night shift up to 12 hours
Cognitive performances : Divided attention test
Tidsramme: Before the night shift
refers to the notion of paying attention to several things at the same time, score obtained from computer tool
Before the night shift
Cognitive performances : Divided attention test
Tidsramme: After the night shift up to 12 hours
refers to the notion of paying attention to several things at the same time, score obtained from computer tool
After the night shift up to 12 hours
Cognitive performances : Flexibility test with alternation
Tidsramme: Before the night shift
refers to the notion of displacement of the attentional focus, score obtained from computer tool
Before the night shift
Cognitive performances : Flexibility test with alternation
Tidsramme: After the night shift up to 12 hours
refers to the notion of displacement of the attentional focus, score obtained from computer tool
After the night shift up to 12 hours
Cognitive performances : Working memory test
Tidsramme: Before the night shift
refers to the notion of maintaining and updating when carrying out complex problems, score obtained from computer tool
Before the night shift
Cognitive performances : Working memory test
Tidsramme: After the night shift up to 12 hours
refers to the notion of maintaining and updating when carrying out complex problems, score obtained from computer tool
After the night shift up to 12 hours
Cognitive performances : Computerized Speed Cognitive Test
Tidsramme: Before the night shift
refers to the notion of the speed of information processing, score obtained from computer tool
Before the night shift
Cognitive performances : Computerized Speed Cognitive Test
Tidsramme: After the night shift up to 12 hours
refers to the notion of the speed of information processing, score obtained from computer tool
After the night shift up to 12 hours
Sleepiness
Tidsramme: Before the night shift
Measured by Karolinska Sleepiness scale, a score of 1 for a great tiredness to 9 for a very well awake state.
Before the night shift
Sleepiness
Tidsramme: After the night shift up to 12 hours
Measured by Karolinska Sleepiness scale, a score of 1 for a great tiredness to 9 for a very well awake state.
After the night shift up to 12 hours
Self esteem
Tidsramme: Before the night shift
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.
Before the night shift
Self esteem
Tidsramme: After the night shift up to 12 hours
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.
After the night shift up to 12 hours

Samarbejdspartnere og efterforskere

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. december 2021

Primær færdiggørelse (Forventet)

1. juni 2023

Studieafslutning (Forventet)

1. september 2023

Datoer for studieregistrering

Først indsendt

18. oktober 2021

Først indsendt, der opfyldte QC-kriterier

23. november 2021

Først opslået (Faktiske)

7. december 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. december 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. november 2021

Sidst verificeret

1. oktober 2021

Mere information

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