Clinical trial NCT06770920: Airway Obstruction During BLS
Official title: Relief Of Airway Obstruction During Basic Life Support And Cardiopulmonary Resuscitation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Education Advancement
Keywords: simulation
education
observer tool
technical skills
basic life support
Lead sponsor: Université Paris-Sud
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: 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 training session on basic life support (BLS) and management of cardiac arrest is taught into 5 successive steps, 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 is 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 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. In a previous trial indeed, the use of an observation tool improved airway management during simulated BLS but this was a secondary outcome and the validity of this result could not be ensured. To increase the positive effects of training when the learner is in the role of observer, some authors have proposed to strengthen the educational effect through the use of an observer tool that observers must complete by analyzing the progress of the task performed by their colleagues. This is a list describing a set of key points to be achieved. However, data concerning the educational value of these observer tools are limited. Studies on the use of these tools during crisis management training in the operating room assessed by high-fidelity simulation have shown improved learning outcomes although some other trials have provided negative results.

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.

This prospective and randomized study will be performed in an academic simulation center during a 8-hour basic emergency skills training in which life support during cardiac arrest lasts nearly 5 hours. Each of the 5 steps is taught incrementally and cumulatively (i.e. when an addition a step is taught, the next practical exercise starts from the 1st step and includes the new one), to familiarize students with technical skills and progression of care and to favor reflexivity by repetitively performing the task. For each step, the trainer initially evaluates the baseline knowledge of students, then provides theoretical information and finally all students perform the cumulative steps in dyads while being observed by the other trainees. The dyad strategy has been previously used and has been chosen to facilitate understanding of task distribution (call for help, lifting the chin during massage, defibrillator search and placement...) and improve training on how to change the rescuer performing the cardiac massage when fatigue arises.

Training days will be randomized according to the following design when learners will perform BLS:

* OT+ group: the observers will use an observer tool (based on technical skills and specifically highlighting actions related to airway management) when they will be not role role-playing. The OT will be provided to learners at the start of the session with a short briefing to explain how to use it. Sheets will be collected at the end of the session.
* OT- group: no observer tool will be used and observers will be encouraged to look at the performance of their peers.

The observer tool used will be based on the 2021 European Resuscitation Council Guidelines (amended when necessary with the 2023 ILCOR recommendations). The observer tool is made of 20 items but has been modified from a previous version to highlight the importance of airway obstruction by increasing the number of items related to airway management.

At the end of each day, students still working in randomly distributed dyads will be video-recorded while playing a short BLS scenario and airway relieving skills will be compared. Medical students will be enrolled after having given their written consent and video copyright. All scenarios will be recorded and anonymously retained and analyzed.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: checklist describing performance of each dyad while performing BLS
timeFrame: From enrollment to the end of treatment at six months
Secondary outcomes:
measure: checklist of the whole observer tool on task performance (20 items)
timeFrame: From enrollment to the end of treatment at six months
measure: Separate analysis of each of the 5 BLS sequences
timeFrame: From enrollment to the end of treatment at six months
measure: questionnaire satisfaction (post session)
timeFrame: From enrollment to the end of treatment at six months
measure: Questionnaire: educational value of an observer tool
timeFrame: From enrollment to the end of treatment at six months
measure: Multiple choice questions
timeFrame: From enrollment to the end of treatment at six months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.