Impact of Stress on Management of BAVU Ventilation (Self-filling Bag With One-way Valve) by Healthcare Professionals. (SIMBAVU 2)

August 6, 2024 updated by: University Hospital, Clermont-Ferrand

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

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.

Study Overview

Status

Recruiting

Conditions

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).

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Clermont-Ferrand, France
        • Recruiting
        • CHU de Clermont-Ferrand
        • Principal Investigator:
          • Thomas GODET
        • Contact:
          • Lise Laclautre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Any healthcare professional who may be required to perform manual ventilation with Self-filling Bag With One-way Valve, available to participate in this work and not opposed to their inclusion in this study.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Unavailability of simulation equipment
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ventilation quality
Time Frame: 1 hour
Quality of ventilation under stress conditions in terms of frequency, pressure and volume delivered compared to the standards of the protective ventilation initially delivered
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Thomas GODET, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • RNI 2024 GODET (SIMBAVU 2)
  • 2024-A00919-38 (Other Identifier: 2024-A00919-38)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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