Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 10:30 PM
Study NCT ID:
NCT05863533
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2023-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resilience, Performance and Stress in Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2023-05-03', 'studyFirstSubmitQcDate': '2023-05-15', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resilience', 'timeFrame': 'at Day 0 : 10 minutes before simulation', 'description': 'Measurement of resilience by Connor-Davidson Resilience Scale 10 (CD RISC 10 from 0 to 40) in participants. A high score indicates better resilience.'}], 'secondaryOutcomes': [{'measure': 'Performance score 1', 'timeFrame': 'at Day 0 during the simulation between T: 0 minute (begin simulation) and T:12 minutes (end of simulation) (during of simulation is 12 minutes))', 'description': 'Performance scale with 15 items based on the recommendations for the management of anaphylactic shock by the French Society of Anaesthesia and Intensive Care. The time taken to perform the procedure is noted and influences the score. The final score ranges from 0 to 60 points. A higher score indicates a higher performance.'}, {'measure': 'Performance score 2', 'timeFrame': 'at D0 during the simulation between T: 0 minute (begin simulation) and T:12 minutes (end of simulation) (during of simulation is 12 minutes)', 'description': 'Performance scale with 15 items based on the recommendations for the management of anaphylactic shock by the French Society of Anaesthesia and Intensive Care. The final score ranges from 0 to 15 points. A higher score indicates a higher performance.'}, {'measure': 'Age of anaesthesia professionals', 'timeFrame': 'at Day 0 : 10 minutes before simulation', 'description': 'Age of anesthesia professionals: (quantitative variable)'}, {'measure': 'work experience', 'timeFrame': 'at Day 0 : 10 minutes before simulation', 'description': 'number of years since first nursing practice (quantitative variable)'}, {'measure': 'year of specialisation', 'timeFrame': 'at Day 0 : 10 minutes before simulation', 'description': 'Year of specialisation : first year or second year(qualitative variable)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resilience', 'Acute stress', 'Performance', 'Anaesthetist student', 'Simulation'], 'conditions': ['Resilience', 'Stress, Psychological']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to determine whether there was an association between resilience and the performance of student nurse anaesthetists in simulated critical situations.', 'detailedDescription': 'This trial will take place at the Grenoble Alpes University Hospital. Volunteer nurse anaesthetists students will perform a simulation scenario. This scenario generates a high level of stress and focuses on the management of anaphylactic shock in the operating room, which is a good teaching tool for the participants.\n\nThe simulation is performed in a dedicated simulation room configured as an operating theatre. In this environment, a high-fidelity manikin is intubated and ventilated on an anaesthesia ventilator. The manikin is perfused. The anaesthesia cart is replicated with the same equipment and drugs as the anaesthesia carts in the operating theatre. A person playing the role of a nurse anaesthetist will conduct transmissions before leaving the room replaced by the participant. One person will play the role of the surgeon in the room. The simulation will take place as follows:\n\nBriefing :\n\nWelcome and explanation of the session. Collection of age, gender, number of years in anaesthesia, number of years as a nurse.\n\nThe simulation room, the mannequin and the anaesthesia trolley are presented by a simulation trainer before starting the scenario.\n\nFirst evaluation of the acute stress perceived by the VAS stress(visual analogue stress scale) which triggers the beginning of the scenario.\n\nThe patient is introduced by the nurse anaesthetist present in the room and explanations are given on how to reach the anaesthetist by phone. Once the transmissions are completed, the preoperative checklist is carried out by the surgeon with the nurse anaesthetist and the student nurse anaesthetist who takes over. Once the checklist is completed the simulation timer is started and the nurse anaesthetist leaves the room leaving the patient alone on the anaesthesia side.\n\nScenario:\n\nOn arrival at the room:\n\n→ Vitals on arrival: BP (blood pressure)= 100/50, HR(heart rate) = 60, Spo2 = 99%, EtC02 (end tidal C02) = 36 mmHg\n\nT0: Surgical incision\n\n→ Vitals at incision: BP = 120/70, HR = 70, SpO2 = 99%, EtCo2 = 39 mmHg\n\nT1 = 3 min: BP = 90/55, HR = 95, SpO2 = 98%, EtCo2 = 34 mmHg\n\nT2 = 6 min: BP = 78/45, HR = 110, SpO2 = 97%, EtCo2 = 30 mmHg, if possible: vary the SpO2 signal if possible\n\nT3 = 9 min: BP = 65/32, HR = 130, SpO2 = no signal, EtCO2 = 28 mmHg\n\nT4 = 12 min: BP = 56/28, HR = 150, SpO2 = no signal, EtCO2 = 25 mmHg\n\nIf no communication with the surgical team before T3, the facilitating surgeon mentions a skin rash to guide management.\n\nThe study stops at 12 minutes when the anaesthetist enters the operating room.\n\nDebriefing: The debriefing is conducted by a simulation trainer accordance with the guidelines of the French Society of Health Simulation.\n\nThe main objective of this study is to investigate an association between the level of resilience of student nurse anaesthetists and their performance (Performance score N°1) under stress.\n\nThe secondary objectives of this study are to investigate the correlation between :\n\n* Performance score N°2 (without taking into account the notion of time in scale N°1) and resilience by ConnorDavison Resilience scale (CDRISC 10).\n* Work experience and performance score 1\n* Years of specialisation in anesthesia and Performance score 1\n* Age and performance score 1'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nurse in the first or second year of specialisation as a nurse anaesthetist.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntary first or second year nurse anaesthetist student\n\nExclusion Criteria:\n\n* pregnant woman'}, 'identificationModule': {'nctId': 'NCT05863533', 'briefTitle': 'Resilience, Performance and Stress in Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Resilience,Performance and Stress in Anaesthesia Professionals: a Simulation-based Observational Study', 'orgStudyIdInfo': {'id': 'IRB 00010254 - 2023 - 030'}}, 'contactsLocationsModule': {'locations': [{'city': 'Grenoble', 'country': 'France', 'facility': 'University Grenoble Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Julien Picard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}