- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05863533
Resilience, Performance and Stress in Anaesthesia
Resilience,Performance and Stress in Anaesthesia Professionals: a Simulation-based Observational Study
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Grenoble, France
- university grenoble hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Voluntary first or second year nurse anaesthetist student
Exclusion Criteria:
- pregnant woman
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resilience
Time Frame: at Day 0 : 10 minutes before simulation
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Measurement of resilience by Connor-Davidson Resilience Scale 10 (CD RISC 10 from 0 to 40) in participants.
A high score indicates better resilience.
|
at Day 0 : 10 minutes before simulation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance score 1
Time Frame: 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.
|
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 score 2
Time Frame: 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.
|
at D0 during the simulation between T: 0 minute (begin simulation) and T:12 minutes (end of simulation) (during of simulation is 12 minutes)
|
|
Age of anaesthesia professionals
Time Frame: at Day 0 : 10 minutes before simulation
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Age of anesthesia professionals: (quantitative variable)
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at Day 0 : 10 minutes before simulation
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work experience
Time Frame: at Day 0 : 10 minutes before simulation
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number of years since first nursing practice (quantitative variable)
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at Day 0 : 10 minutes before simulation
|
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year of specialisation
Time Frame: at Day 0 : 10 minutes before simulation
|
Year of specialisation : first year or second year(qualitative variable)
|
at Day 0 : 10 minutes before simulation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julien Picard, University Hospital, Grenoble
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 00010254 - 2023 - 030
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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