NCT06770920

Brief Summary

Appropriate management of cardiac arrest (immediately and technically well performed) is a priority that must be taught to all citizens and future healthcare personnel, including future physicians. In this medical school, 2nd year medical students receive a 8 hour training session on basic life support (BLS) and management of cardiac arrest is taught into 5 successive parts, with learning and cumulative repetition of the steps: detection of unconsciousness, call for help, absence of breathing, cardiac massage and defibrillation. During the many sessions previously carried out by our team, it often appeared that students, when evaluating breathing forget the 1st part related to airway and breathing, i.e. relieving airway obstruction. Yet it has been shown that opening the airway and early removal of a foreign body are associated with improved neurological survival. Importantly, mouth-to-mouth is not included in the learning session and compression-only is advocated. The purpose of the present study is to evaluate if the use of an observation tool, with items centered on airway obstruction, can improve learning of this step, as shown in some previous trials. This will be a trial performed in medical students in which training days will be randomized to include or not the use of an observation tool modified to emphasize the procedural parts that are aimed at relieving airway obstruction. At the end of each day, students will be video-recorded while playing a short BLS scenario and airway obstruction-relieving skills will be compared.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Status
not yet 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

December 31, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 13, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

10 days

First QC Date

December 31, 2024

Last Update Submit

January 7, 2025

Conditions

Keywords

simulationeducationobserver tooltechnical skillsbasic life support

Outcome Measures

Primary Outcomes (1)

  • checklist describing performance of each dyad while performing BLS

    comparison of airway management skills, i.e. measured by external evaluation from the six items of the checklist related to this task between the OT + group and the OT- group among the checklist of items describing in detail the actions performed during BLS maximum score of 6/6 higher scores mean a better outcome Each item is scored 1 point

    From enrollment to the end of treatment at six months

Secondary Outcomes (5)

  • checklist of the whole observer tool on task performance (20 items)

    From enrollment to the end of treatment at six months

  • Separate analysis of each of the 5 BLS sequences

    From enrollment to the end of treatment at six months

  • questionnaire satisfaction (post session)

    From enrollment to the end of treatment at six months

  • Questionnaire: educational value of an observer tool

    From enrollment to the end of treatment at six months

  • Multiple choice questions

    From enrollment to the end of treatment at six months

Study Arms (2)

observer tool +

EXPERIMENTAL

use an observer tool

Other: use of an observer tool when not role-playing

observer tool -

NO INTERVENTION

In this group, the students will not be given the observer tool and will observe other residents without any additional form.

Interventions

Observers will use an observer tool (based on technical skills and specifically related to airway management during BLS) when they will be not role role-playing.

observer tool +

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • medical students participating in a full-day of basic life support training at the LabforSIMS- of Paris-Saclay medical school

You may not qualify if:

  • declines active participation in the session
  • no video-recording during simulation (i.e. technical problem)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Goulamhoussen A, Havard C, Gille B, Francois B, Benhamou D, Blanie A. An observer tool to enhance learning of medical students during simulation training of cardiopulmonary resuscitation: a randomised controlled trial. BMC Med Educ. 2024 Jul 3;24(1):719. doi: 10.1186/s12909-024-05658-x.

  • Olasveengen TM, Semeraro F, Ristagno G, Castren M, Handley A, Kuzovlev A, Monsieurs KG, Raffay V, Smyth M, Soar J, Svavarsdottir H, Perkins GD. European Resuscitation Council Guidelines 2021: Basic Life Support. Resuscitation. 2021 Apr;161:98-114. doi: 10.1016/j.resuscitation.2021.02.009. Epub 2021 Mar 24.

  • Couper K, Abu Hassan A, Ohri V, Patterson E, Tang HT, Bingham R, Olasveengen T, Perkins GD; International Liaison Committee on Resuscitation Basic and Paediatric Life Support Task Force Collaborators. Removal of foreign body airway obstruction: A systematic review of interventions. Resuscitation. 2020 Nov;156:174-181. doi: 10.1016/j.resuscitation.2020.09.007. Epub 2020 Sep 16.

Central Study Contacts

Antonia BLANIE, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

December 31, 2024

First Posted

January 13, 2025

Study Start

January 13, 2025

Primary Completion

January 23, 2025

Study Completion

September 1, 2025

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share