NCT06481618

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

July 24, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 7, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 25, 2024

Last Update Submit

August 6, 2024

Conditions

Any Healthcare ProfessionalAgreement to ParticipateWho May be Required to Perform Manual Ventilation

Outcome Measures

Primary Outcomes (1)

  • ventilation quality

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Unavailability of simulation equipment
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

Study Officials

  • Thomas Godet

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 1, 2024

Study Start

July 24, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

August 7, 2024

Record last verified: 2024-06

Locations

FR(1)