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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 aktualisiert von: 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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

60

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Clermont-Ferrand, Frankreich, 63000
        • Clermont-Ferrand University Hospital
        • Hauptermittler:
          • Alexandre LAUTRETTE

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

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)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Residents' non technical skills after a night shift
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Residents' non technical skill before a night shift
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

1. Dezember 2021

Primärer Abschluss (Voraussichtlich)

1. Juni 2023

Studienabschluss (Voraussichtlich)

1. September 2023

Studienanmeldedaten

Zuerst eingereicht

18. Oktober 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. November 2021

Zuerst gepostet (Tatsächlich)

7. Dezember 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Dezember 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. November 2021

Zuletzt verifiziert

1. Oktober 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

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Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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