Ignite Creation Date:
2024-07-17 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481618
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-25
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:
University Hospital Clermont-Ferrand
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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-A00919-38 | OTHER | None | None |