LeadershipNCT05309434
Effects of CPR Coaching on Leader's Performance During Simulated Cardiac Arrest
A study testing Coach in people with Leadership, run by European e-Learning School in Obstetric Anesthesia at 1 site in Italy.
Trial summary
Previous studies reported that the introduction of the role of the CPR Coach in resuscitation teams led to an increase in the adherence of CPR to AHA guidelines by the team. To date, the interaction between the CPR Coach and the Team Leader during the performance of CPR remains poorly studied. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Leadership
- What is being tested?
- Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2022to 28 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Anesthesia trainees
- Emergency medicine trainees
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Giulia Mormando, MD contact
Italy1 site
Azienda Universitaria Ospedaliera
Padova
Giulia Mormando, MD, +39-3493104132, giulia.mormando@gmail.com
About this study
Previous studies reported that the introduction of the role of the CPR Coach in resuscitation teams led to an increase in the adherence of CPR to AHA guidelines by the team.
To date, the interaction between the CPR Coach and the Team Leader during the performance of CPR remains poorly studied.
In this study, the investigators aim to evaluate whether the interaction between the CPR Coach and the Team Leader brings real benefits to the cognitive engagement of the latter and therefore whether or not his leadership and the overall performance of the team is affected.
Read the detailed description
In this study, 60 trainees will be divided into 10 teams of 6 participants each, which include two CPR providers, a team leader, a nurse actor, a defibrillator actor with (study groups A and B) or without (control group, C) a coach.
Each team will perform a standardized 10-minute cardiopulmonary resuscitation (CPR) simulation on a standardized Trauma Hal mannequin (Gaumard Scientific) with a Combat Application Tourniquet (CAT Resources, Rock Hill, SC)/SUSIE simulator(Gaumard Scientific, Miami, FL) with a CPR Feedback device. All participants assigned the role of the coach will receive standardized training as described by Cheng et al, 2018.
Study group A will run the simulation with the CPR coach figure standing next to the defibrillator; study group B will run the simulation with the CPR coach free to move around the scenario; control group C will run the simulation without the CPR coach. During the simulations, an experienced facilitator and a simulation technician will be present to conduct and oversee the progress of the activities.
All activities of all teams will be recorded with cameras and microphones. At the end of each simulation, there will be a debriefing conducted by an expert facilitator to make the simulation experience complete but will not be considered in the study.
All recorded videos will be viewed by 4 experts who will score the leader's performance and the team's performance. The leader's performance will be evaluated by using the Resuscitation Team Leader Evaluation Scale (RTLE) (Grant et al,2012). The Team's overall performance will be evaluated by the Clinical Performance Toll (CPT)(Donoghue et al, 2010).
- Conditions
- Leadership
- Being tested
- Coach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoachBehavioural
The coach coordinates the initiation of CPR, communicates feedback device data to assist those performing compressions, communicates average targets for compressions and ventilations and coordinates operations to achieve those values, and communicates with the team to reduce pauses in compressions.
| Study group | Role | What they receive |
|---|---|---|
| Study group with standing coach | Experimental | The team performs the simulated CPR with the coach standing next to the defibrillator Receives: Behavioral: Coach |
| study group with mobile coach | Experimental | The team performs the simulated CPR with the coach free to move around the simulation room Receives: Behavioral: Coach |
| control group without coach | No intervention | The team performs the simulated CPR without the coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Team leader performance
Evaluation of team leader's performance by using the Resuscitation Team Leader Evaluation Scale (RTLE) (0=not performed or not observed; 1= performed but ineffectively, incompletely, or inconsistently; 2=performed adequately most of the time; 3= performed well consistently). High scores are the better outcome.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion28 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LeadershipStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European e-Learning School in Obstetric Anesthesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgio Capogna, MD, Study director, European e-Learning School in Obstetric Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309434
- Sponsor's protocol ID
- EESOA11
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grant EC, Grant VJ, Bhanji F, Duff JP, Cheng A, Lockyer JM. The development and assessment of an evaluation tool for pediatric resident competence in leading simulated pediatric resuscitations. Resuscitation. 2012 Jul;83(7):887-93. doi: 10.1016/j.resuscitation.2012.01.015. Epub 2012 Jan 28.
PubMed 22286047Cheng A, Duff JP, Kessler D, Tofil NM, Davidson J, Lin Y, Chatfield J, Brown LL, Hunt EA; International Network for Simulation-based Pediatric Innovation Research and Education (INSPIRE) CPR. Optimizing CPR performance with CPR coaching for pediatric cardiac arrest: A randomized simulation-based clinical trial. Resuscitation. 2018 Nov;132:33-40. doi: 10.1016/j.resuscitation.2018.08.021. Epub 2018 Aug 24.
PubMed 30149088Donoghue A, Nishisaki A, Sutton R, Hales R, Boulet J. Reliability and validity of a scoring instrument for clinical performance during Pediatric Advanced Life Support simulation scenarios. Resuscitation. 2010 Mar;81(3):331-6. doi: 10.1016/j.resuscitation.2009.11.011. Epub 2010 Jan 4.
PubMed 20047787Mormando G, Capogna E, Costantini I, Savino S, Vittadello A, Campione M, Boscolo A, Bressan S, Navalesi P. The impact of CPR coach presence and position on team leader and team performance during asystole simulation scenario: a randomized simulation-based trial. PLoS One. 2026 Mar 12;21(3):e0344568. doi: 10.1371/journal.pone.0344568. eCollection 2026.
PubMed 41818218
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of CPR Coaching on Leader's Performance During Simulated Cardiac Arrest
- ClinicalTrials.gov ID
- NCT05309434
- Acronym / sponsor ID
- EESOA11
- Conditions
- Leadership
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- European e-Learning School in Obstetric AnesthesiaUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 28 Oct 2022 (estimated)
- First posted
- 4 Apr 2022 (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.
Previous studies reported that the introduction of the role of the CPR Coach in resuscitation teams led to an increase in the adherence of CPR to AHA guidelines by the team.
To date, the interaction between the CPR Coach and the Team Leader during the performance of CPR remains poorly studied.
In this study, the investigators aim to evaluate whether the interaction between the CPR Coach and the Team Leader brings real benefits to the cognitive engagement of the latter and therefore whether or not his leadership and the overall performance of the team is affected.
Detailed description
In this study, 60 trainees will be divided into 10 teams of 6 participants each, which include two CPR providers, a team leader, a nurse actor, a defibrillator actor with (study groups A and B) or without (control group, C) a coach.
Each team will perform a standardized 10-minute cardiopulmonary resuscitation (CPR) simulation on a standardized Trauma Hal mannequin (Gaumard Scientific) with a Combat Application Tourniquet (CAT Resources, Rock Hill, SC)/SUSIE simulator(Gaumard Scientific, Miami, FL) with a CPR Feedback device. All participants assigned the role of the coach will receive standardized training as described by Cheng et al, 2018.
Study group A will run the simulation with the CPR coach figure standing next to the defibrillator; study group B will run the simulation with the CPR coach free to move around the scenario; control group C will run the simulation without the CPR coach. During the simulations, an experienced facilitator and a simulation technician will be present to conduct and oversee the progress of the activities.
All activities of all teams will be recorded with cameras and microphones. At the end of each simulation, there will be a debriefing conducted by an expert facilitator to make the simulation experience complete but will not be considered in the study.
All recorded videos will be viewed by 4 experts who will score the leader's performance and the team's performance. The leader's performance will be evaluated by using the Resuscitation Team Leader Evaluation Scale (RTLE) (Grant et al,2012). The Team's overall performance will be evaluated by the Clinical Performance Toll (CPT)(Donoghue et al, 2010).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group with standing coach | Experimental | Behavioral: CoachThe team performs the simulated CPR with the coach standing next to the defibrillator |
| study group with mobile coach | Experimental | Behavioral: CoachThe team performs the simulated CPR with the coach free to move around the simulation room |
| control group without coach | No intervention | –The team performs the simulated CPR without the coach |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Anesthesia trainees
- Emergency medicine trainees
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| CoachThe coach coordinates the initiation of CPR, communicates feedback device data to assist those performing compressions, communicates average targets for compressions and ventilations and coordinates operations to achieve those values, and communicates with the team to reduce pauses in compressions. | Behavioural | Study group with standing coach, study group with mobile coach |
Primary outcome
Team leader performance
Time frame: 30 minutes
Evaluation of team leader's performance by using the Resuscitation Team Leader Evaluation Scale (RTLE) (0=not performed or not observed; 1= performed but ineffectively, incompletely, or inconsistently; 2=performed adequately most of the time; 3= performed well consistently). High scores are the better outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Background: PubMed 22286047Grant EC, Grant VJ, Bhanji F, Duff JP, Cheng A, Lockyer JM. The development and assessment of an evaluation tool for pediatric resident competence in leading simulated pediatric resuscitations. Resuscitation. 2012 Jul;83(7):887-93. doi: 10.1016/j.resuscitation.2012.01.015. Epub 2012 Jan 28.
- Background: PubMed 30149088Cheng A, Duff JP, Kessler D, Tofil NM, Davidson J, Lin Y, Chatfield J, Brown LL, Hunt EA; International Network for Simulation-based Pediatric Innovation Research and Education (INSPIRE) CPR. Optimizing CPR performance with CPR coaching for pediatric cardiac arrest: A randomized simulation-based clinical trial. Resuscitation. 2018 Nov;132:33-40. doi: 10.1016/j.resuscitation.2018.08.021. Epub 2018 Aug 24.
- Background: PubMed 20047787Donoghue A, Nishisaki A, Sutton R, Hales R, Boulet J. Reliability and validity of a scoring instrument for clinical performance during Pediatric Advanced Life Support simulation scenarios. Resuscitation. 2010 Mar;81(3):331-6. doi: 10.1016/j.resuscitation.2009.11.011. Epub 2010 Jan 4.
- Derived from this study: PubMed 41818218Mormando G, Capogna E, Costantini I, Savino S, Vittadello A, Campione M, Boscolo A, Bressan S, Navalesi P. The impact of CPR coach presence and position on team leader and team performance during asystole simulation scenario: a randomized simulation-based trial. PLoS One. 2026 Mar 12;21(3):e0344568. doi: 10.1371/journal.pone.0344568. eCollection 2026.
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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. This study is not recruiting at the moment.
Giulia Mormando, MD contact
Giorgio Capogna, MD study director
European e-Learning School in Obstetric Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coach in people with Leadership, run by European e-Learning School in Obstetric Anesthesia at 1 site in Italy.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emanuele Capogna (3294014731, ema.capogna@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Team leader performance (time frame: 30 minutes). 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 NCT05309434, which also lists 4 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 15 Apr 2022.