Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT05146856
Status:
UNKNOWN
Last Update Posted:
2021-12-07
First Post:
2021-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of a Day Without Clinical Activity Before Night Shift on Non-technical Skills of Intensive Care Residents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-23', 'studyFirstSubmitDate': '2021-10-18', 'studyFirstSubmitQcDate': '2021-11-23', 'lastUpdatePostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Residents' non technical skills after a night shift", 'timeFrame': 'Immediatly after the end of the night shift', 'description': '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.'}], 'secondaryOutcomes': [{'measure': "Residents' non technical skill before a night shift", 'timeFrame': 'Baseline, before the night shift', 'description': '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.'}, {'measure': 'Cognitive performances : Phasic alert test', 'timeFrame': 'Before the night shift', 'description': 'refers to the notion of general wakefulness allowing to react quickly and appropriately to requests, score obtained from computer tool'}, {'measure': 'Cognitive performances : Phasic alert test', 'timeFrame': 'After the night shift up to 12 hours', 'description': 'refers to the notion of general wakefulness allowing to react quickly and appropriately to requests, score obtained from computer tool'}, {'measure': 'Cognitive performances : Divided attention test', 'timeFrame': 'Before the night shift', 'description': 'refers to the notion of paying attention to several things at the same time, score obtained from computer tool'}, {'measure': 'Cognitive performances : Divided attention test', 'timeFrame': 'After the night shift up to 12 hours', 'description': 'refers to the notion of paying attention to several things at the same time, score obtained from computer tool'}, {'measure': 'Cognitive performances : Flexibility test with alternation', 'timeFrame': 'Before the night shift', 'description': 'refers to the notion of displacement of the attentional focus, score obtained from computer tool'}, {'measure': 'Cognitive performances : Flexibility test with alternation', 'timeFrame': 'After the night shift up to 12 hours', 'description': 'refers to the notion of displacement of the attentional focus, score obtained from computer tool'}, {'measure': 'Cognitive performances : Working memory test', 'timeFrame': 'Before the night shift', 'description': 'refers to the notion of maintaining and updating when carrying out complex problems, score obtained from computer tool'}, {'measure': 'Cognitive performances : Working memory test', 'timeFrame': 'After the night shift up to 12 hours', 'description': 'refers to the notion of maintaining and updating when carrying out complex problems, score obtained from computer tool'}, {'measure': 'Cognitive performances : Computerized Speed Cognitive Test', 'timeFrame': 'Before the night shift', 'description': 'refers to the notion of the speed of information processing, score obtained from computer tool'}, {'measure': 'Cognitive performances : Computerized Speed Cognitive Test', 'timeFrame': 'After the night shift up to 12 hours', 'description': 'refers to the notion of the speed of information processing, score obtained from computer tool'}, {'measure': 'Sleepiness', 'timeFrame': 'Before the night shift', 'description': 'Measured by Karolinska Sleepiness scale, a score of 1 for a great tiredness to 9 for a very well awake state.'}, {'measure': 'Sleepiness', 'timeFrame': 'After the night shift up to 12 hours', 'description': 'Measured by Karolinska Sleepiness scale, a score of 1 for a great tiredness to 9 for a very well awake state.'}, {'measure': 'Self esteem', 'timeFrame': 'Before the night shift', 'description': '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.'}, {'measure': 'Self esteem', 'timeFrame': 'After the night shift up to 12 hours', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Personnel Staffing and Scheduling', 'High fidelity simulation', 'Medical Errors / prevention & control', 'Psychomotor Performance / physiology', 'Sleep', 'Work Schedule Tolerance', 'Internship and Residency / organization & administration', 'Cross-Over Studies', 'Humans'], 'conditions': ['Physician Fatigue']}, 'descriptionModule': {'briefSummary': "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:\n\nTo 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\n\nTo 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", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators will include volunteer residents in anesthesia of critical care medicine of Gabriel Montpied university hospital of Clermont Ferrand.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* residents in Anesthesia or Critical care medicine\n* Who effect night shift in intensive care unit\n* Able to take a day off clinic before night shift\n* Able to give consent\n\nExclusion Criteria:\n\n* Refusal of participation'}, 'identificationModule': {'nctId': 'NCT05146856', 'acronym': 'REPOPREGARD', 'briefTitle': 'Impact of a Day Without Clinical Activity Before Night Shift on Non-technical Skills of Intensive Care Residents', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2021 LAUTRETTE REPOPREGARDE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Residents in control group have a usual day with clinical activity before night shift'}, {'label': 'Intervention', 'description': 'Residents in intervention group have a day off clinic before night shift (i.e day off or day with university activity)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'contacts': [{'name': 'Lise Laclautre', 'role': 'CONTACT', 'email': 'promo_interne_drci@chu-clermontferrand.fr'}, {'name': 'Alexandre LAUTRETTE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clermont-Ferrand University Hospital', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Lise Laclautre', 'role': 'CONTACT', 'email': 'promo_interne_drci@chu-clermontferrand.fr', 'phone': '+33 4 73 754963'}, {'name': 'Vedat Eljezi', 'role': 'CONTACT', 'email': 'veljezi@chu-clermontferrand.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}