- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05309434
Effects of CPR Coaching on Leader's Performance During Simulated Cardiac Arrest
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.
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emanuele Capogna
- Phone Number: 3294014731
- Email: ema.capogna@gmail.com
Study Contact Backup
- Name: Giulia Mormando, MD
- Email: giulia.mormando@gmail.com
Study Locations
-
-
-
Padova, Italy
- Azienda Universitaria Ospedaliera
-
Contact:
- Giulia Mormando, MD
- Phone Number: +39-3493104132
- Email: giulia.mormando@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Anesthesia trainees
- Emergency medicine trainees
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Study group with standing coach
The team performs the simulated CPR with the coach standing next to the defibrillator
|
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.
|
|
EXPERIMENTAL: study group with mobile coach
The team performs the simulated CPR with the coach free to move around the simulation room
|
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.
|
|
NO_INTERVENTION: control group without coach
The team performs the simulated CPR without the coach
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
30 minutes
|
Collaborators and Investigators
Publications and helpful links
General 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.
- Cheng 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.
- Donoghue 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EESOA11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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