Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-09 @ 7:04 AM
Study NCT ID:
NCT06481618
Status:
RECRUITING
Last Update Posted:
2024-08-07
First Post:
2024-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Stress on Management of BAVU Ventilation (Self-filling Bag With One-way Valve) by Healthcare Professionals.
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Impact of Stress the Management of BAVU Ventilation (Self-filling Bag With One-way Valve) by Healthcare Professionals.
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIMBAVU 2
Brief Summary:
The goal of this observational study is to learn about the impact of stress on the manual ventilation through Self-filling Bag With One-way Valve. The main question it aims to answer :
how does the ocurence of a stressfull event modify the ventilation delivered in term of pressure, frequency, volume.
Volunter healthcare professionals will take part in a simulation where they will manually ventilate a manikin and ventilation datas will be recorded.
how does the ocurence of a stressfull event modify the ventilation delivered in term of pressure, frequency, volume.
Volunter healthcare professionals will take part in a simulation where they will manually ventilate a manikin and ventilation datas will be recorded.
Detailed Description:
The lung simulator (ASL 5000TM, IngMar Medical) will be connected to a high-fidelity mannequin (SimMan 3G, Laerdal Medical). A continuous, cycle-by-cycle recording of the administered ventilatory parameters will be carried out (recording of pressure, volume and flow curves as a function of time). These curves will then make it possible to determine the main parameters of this ventilation (respiratory frequency, maximum and end-expiratory pressure, tidal volume, etc.).
The healthcare professional will be asked to carry out ventilation with Self-filling Bag With One-way Valve as he is accustomed to doing, during a standardized patient transfer.
Subsequently, an unforeseen event will be added to the situation with continued continuous recording of ventilation modalities.
The personal data that will be requested from healthcare professionals will be: their age, their gender, their seniority in the profession, their place of practice. The stress of healthcare professionals will be assessed using a digital self-assessment scale and the use of a heart rate monitor.
Prior stress and anxiety will be measured in advance by completing several questionnaires before starting the simulation (STAI-T, STAI E, AD ACL).
The healthcare professional will be asked to carry out ventilation with Self-filling Bag With One-way Valve as he is accustomed to doing, during a standardized patient transfer.
Subsequently, an unforeseen event will be added to the situation with continued continuous recording of ventilation modalities.
The personal data that will be requested from healthcare professionals will be: their age, their gender, their seniority in the profession, their place of practice. The stress of healthcare professionals will be assessed using a digital self-assessment scale and the use of a heart rate monitor.
Prior stress and anxiety will be measured in advance by completing several questionnaires before starting the simulation (STAI-T, STAI E, AD ACL).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-A00919-38 | OTHER | 2024-A00919-38 | View |