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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05309434
Other study ID # EESOA11
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date October 28, 2022

Study information

Verified date April 2022
Source European e-Learning School in Obstetric Anesthesia
Contact Emanuele Capogna
Phone 3294014731
Email ema.capogna@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date October 28, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 40 Years
Eligibility Inclusion Criteria: - Anesthesia trainees - Emergency medicine trainees Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Coach
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.

Locations

Country Name City State
Italy Azienda Universitaria Ospedaliera Padova

Sponsors (1)

Lead Sponsor Collaborator
European e-Learning School in Obstetric Anesthesia

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 minutes
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