Education AdvancementBLS-OBSTNCT06770920
Airway Obstruction During BLS
A study testing use of an observer tool when not role-playing in people with Education Advancement, run by Université Paris-Sud.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Education Advancement
- What is being tested?
- use of an observer tool when not role-playing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medical students participating in a full-day of basic life support training at the LabforSIMS- of Paris-Saclay medical school
Who cannot join
- declines active participation in the session
- no video-recording during simulation (i.e. technical problem)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Antonia BLANIE, MD, PhD contact
About this study
Official title: Relief Of Airway Obstruction During Basic Life Support And Cardiopulmonary Resuscitation
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.
Read more
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.
Read the 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.
- Conditions
- Education Advancement
- Being tested
- use of an observer tool when not role-playing
- Keywords
- simulation, education, observer tool, technical skills, basic life support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of an observer tool when not role-playingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| observer tool + | Experimental | use an observer tool Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at six months
Secondary outcomes (5)
checklist of the whole observer tool on task performance (20 items)
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
Measured: From enrollment to the end of treatment at six months
Separate analysis of each of the 5 BLS sequences
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
Measured: From enrollment to the end of treatment at six months
questionnaire satisfaction (post session)
Satisfaction will be assessed by a Likert scale (0 to 10) (Kirkpatrick level 1
Measured: From enrollment to the end of treatment at six months
Questionnaire: educational value of an observer tool
Perception about the educational value of an observer tool by a Likert scale (0 to 10) (Kirkpatrick level 1)
Measured: From enrollment to the end of treatment at six months
Multiple choice questions
6 questions evaluating knowledge about BLS actions Maximum score 6 /6
Measured: From enrollment to the end of treatment at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start13 Jan 2025 (estimated)
- Primary completion23 Jan 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Education AdvancementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Paris-Sud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Benhamou, Université Paris-Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770920
- Sponsor's protocol ID
- LabForSIMS 007
- Acronym
- BLS-OBST
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38961381Olasveengen 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.
PubMed 33773835Couper 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.
PubMed 32949674
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relief Of Airway Obstruction During Basic Life Support And Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT06770920
- Acronym / sponsor ID
- BLS-OBST / LabForSIMS 007
- Conditions
- Education Advancement
- Keywords
- simulation, education, observer tool, technical skills, basic life support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Université Paris-SudUniversity, hospital or other
- Study start
- 13 Jan 2025 (estimated)
- Primary completion
- 23 Jan 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observer tool + | Experimental | Other: use of an observer tool when not role-playinguse an observer tool |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- medical students participating in a full-day of basic life support training at the LabforSIMS- of Paris-Saclay medical school
Key exclusion criteria (2 listed)
- declines active participation in the session
- no video-recording during simulation (i.e. technical problem)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of an observer tool when not role-playingObservers 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. | Other | observer tool + |
Primary outcome
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
5 secondary outcomes
checklist of the whole observer tool on task performance (20 items)
Time frame: From enrollment to the end of treatment at six months
Separate analysis of each of the 5 BLS sequences
Time frame: From enrollment to the end of treatment at six months
questionnaire satisfaction (post session)
Time frame: From enrollment to the end of treatment at six months
Questionnaire: educational value of an observer tool
Time frame: From enrollment to the end of treatment at six months
Multiple choice questions
Time frame: From enrollment to the end of treatment at six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Results publication: PubMed 38961381Goulamhoussen 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.
- Results publication: PubMed 33773835Olasveengen 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.
- Results publication: PubMed 32949674Couper 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonia BLANIE, MD, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing use of an observer tool when not role-playing in people with Education Advancement, run by Université Paris-Sud.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Benhamou, MD (33 1 45 21 63 10, dan.benhamou@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
checklist describing performance of each dyad while performing BLS (time frame: From enrollment to the end of treatment at six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06770920, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.