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NCT Number: NCT06770920

Airway Obstruction During BLS

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

use of an observer tool when not role-playing

Other

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.

Primary outcomes

  1. checklist describing performance of each dyad while performing BLS

    Time frame: From enrollment to the end of treatment at six months

    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

Secondary outcomes

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

    Time frame: From enrollment to the end of treatment at six months

    Global performance of each dyad measured by external evaluation while performing BLS by comparing overall management skills, i.e. the 20 items between the OT + group and the OT- group maximum score of 20/20 higher scores mean a better outcome Each item is scored 1 point

  2. Separate analysis of each of the 5 BLS sequences

    Time frame: From enrollment to the end of treatment at six months

    comparison of the performance of the two groups for each step of the checklist : detection of unconsciousness (4 items), call for help (4 items), absence of breathing (7 items), cardiac massage (5 items) and defibrillation (5 items). Each of the 5 steps is measured by external evaluation Each item is scored 1 point Higher scores indicate better performance

  3. questionnaire satisfaction (post session)

    Time frame: From enrollment to the end of treatment at six months

    Satisfaction will be assessed by a Likert scale (0 to 10) (Kirkpatrick level 1

  4. Questionnaire: educational value of an observer tool

    Time frame: From enrollment to the end of treatment at six months

    Perception about the educational value of an observer tool by a Likert scale (0 to 10) (Kirkpatrick level 1)

  5. Multiple choice questions

    Time frame: From enrollment to the end of treatment at six months

    6 questions evaluating knowledge about BLS actions Maximum score 6 /6

Study contacts

Contact information is provided by the study sponsor or research team.

Antonia BLANIE, MD, PhD

CONTACT

33 1 45 21 34 47

Dan Benhamou, MD

CONTACT

[email protected]

33 1 45 21 63 10

Sponsors and collaborators

Lead sponsor

Université Paris-Sud

Other

Registry information

Official study title

Relief Of Airway Obstruction During Basic Life Support And Cardiopulmonary Resuscitation

Acronym: BLS-OBST

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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