Resilience, Performance and Stress in Anaesthesia

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05863533
Collaborator
(none)
30
3.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    The 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:

    Briefing :

    Welcome and explanation of the session. Collection of age, gender, number of years in anaesthesia, number of years as a nurse.

    The simulation room, the mannequin and the anaesthesia trolley are presented by a simulation trainer before starting the scenario.

    First evaluation of the acute stress perceived by the VAS stress(visual analogue stress scale) which triggers the beginning of the scenario.

    The 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.

    Scenario:
    On arrival at the room:

    → Vitals on arrival: BP (blood pressure)= 100/50, HR(heart rate) = 60, Spo2 = 99%, EtC02 (end tidal C02) = 36 mmHg

    T0: Surgical incision

    → Vitals at incision: BP = 120/70, HR = 70, SpO2 = 99%, EtCo2 = 39 mmHg

    T1 = 3 min: BP = 90/55, HR = 95, SpO2 = 98%, EtCo2 = 34 mmHg

    T2 = 6 min: BP = 78/45, HR = 110, SpO2 = 97%, EtCo2 = 30 mmHg, if possible: vary the SpO2 signal if possible

    T3 = 9 min: BP = 65/32, HR = 130, SpO2 = no signal, EtCO2 = 28 mmHg

    T4 = 12 min: BP = 56/28, HR = 150, SpO2 = no signal, EtCO2 = 25 mmHg

    If no communication with the surgical team before T3, the facilitating surgeon mentions a skin rash to guide management.

    The study stops at 12 minutes when the anaesthetist enters the operating room.

    Debriefing: The debriefing is conducted by a simulation trainer accordance with the guidelines of the French Society of Health Simulation.

    The 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.

    The secondary objectives of this study are to investigate the correlation between :
    • Performance score N°2 (without taking into account the notion of time in scale N°1) and resilience by ConnorDavison Resilience scale (CDRISC 10).

    • Work experience and performance score 1

    • Years of specialisation in anesthesia and Performance score 1

    • Age and performance score 1

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Resilience,Performance and Stress in Anaesthesia Professionals: a Simulation-based Observational Study
    Anticipated Study Start Date :
    May 15, 2023
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Resilience [at Day 0 : 10 minutes before simulation]

      Measurement of resilience by Connor-Davidson Resilience Scale 10 (CD RISC 10 from 0 to 40) in participants. A high score indicates better resilience.

    Secondary Outcome Measures

    1. Performance score 1 [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))]

      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.

    2. Performance score 2 [at D0 during the simulation between T: 0 minute (begin simulation) and T:12 minutes (end of simulation) (during of simulation is 12 minutes)]

      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.

    3. Age of anaesthesia professionals [at Day 0 : 10 minutes before simulation]

      Age of anesthesia professionals: (quantitative variable)

    4. work experience [at Day 0 : 10 minutes before simulation]

      number of years since first nursing practice (quantitative variable)

    5. year of specialisation [at Day 0 : 10 minutes before simulation]

      Year of specialisation : first year or second year(qualitative variable)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Voluntary first or second year nurse anaesthetist student
    Exclusion Criteria:
    • pregnant woman

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Grenoble

    Investigators

    • Principal Investigator: Julien Picard, University Hospital, Grenoble

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Grenoble
    ClinicalTrials.gov Identifier:
    NCT05863533
    Other Study ID Numbers:
    • IRB 00010254 - 2023 - 030
    First Posted:
    May 18, 2023
    Last Update Posted:
    May 18, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Grenoble
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 18, 2023