Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05863533 |
| Other study ID # |
IRB 00010254 - 2023 - 030 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2023 |
| Est. completion date |
September 1, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
University Hospital, Grenoble |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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
