Impact of Stress on Management of BAVU Ventilation (Self-filling Bag With One-way Valve) by Healthcare Professionals.

NCT ID: NCT06481618

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-24

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Any Healthcare Professional Agreement to Participate Who May be Required to Perform Manual Ventilation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Any healthcare professional who may be required to perform manual ventilation

Exclusion Criteria

* Unavailability of simulation equipment
* Refusal to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Godet

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lise Laclautre

Role: CONTACT

334.73.754.963

Facility Contacts

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Lise Laclautre

Role: primary

Other Identifiers

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2024-A00919-38

Identifier Type: OTHER

Identifier Source: secondary_id

RNI 2024 GODET (SIMBAVU 2)

Identifier Type: -

Identifier Source: org_study_id

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