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Effects of CPR Coaching on Leader's Performance During Simulated Cardiac Arrest

Primary Purpose

Leadership

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Coach
Sponsored by
European e-Learning School in Obstetric Anesthesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Leadership

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Anesthesia trainees
  • Emergency medicine trainees

Exclusion Criteria:

  • none

Sites / Locations

  • Azienda Universitaria Ospedaliera

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Study group with standing coach

study group with mobile coach

control group without coach

Arm Description

The team performs the simulated CPR with the coach standing next to the defibrillator

The team performs the simulated CPR with the coach free to move around the simulation room

The team performs the simulated CPR without the coach

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 22, 2022
Last Updated
April 13, 2022
Sponsor
European e-Learning School in Obstetric Anesthesia
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1. Study Identification

Unique Protocol Identification Number
NCT05309434
Brief Title
Effects of CPR Coaching on Leader's Performance During Simulated Cardiac Arrest
Official Title
Effects of CPR Coaching on Leader's Performance During Simulated Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
October 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European e-Learning School in Obstetric Anesthesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leadership

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group with standing coach
Arm Type
Experimental
Arm Description
The team performs the simulated CPR with the coach standing next to the defibrillator
Arm Title
study group with mobile coach
Arm Type
Experimental
Arm Description
The team performs the simulated CPR with the coach free to move around the simulation room
Arm Title
control group without coach
Arm Type
No Intervention
Arm Description
The team performs the simulated CPR without the coach
Intervention Type
Behavioral
Intervention Name(s)
Coach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Team leader performance
Description
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.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Anesthesia trainees Emergency medicine trainees Exclusion Criteria: none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emanuele Capogna
Phone
3294014731
Email
ema.capogna@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Giulia Mormando, MD
Email
giulia.mormando@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgio Capogna, MD
Organizational Affiliation
European e-Learning School in Obstetric Anesthesia
Official's Role
Study Director
Facility Information:
Facility Name
Azienda Universitaria Ospedaliera
City
Padova
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giulia Mormando, MD
Phone
+39-3493104132
Email
giulia.mormando@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
22286047
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.
Results Reference
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PubMed Identifier
30149088
Citation
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.
Results Reference
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PubMed Identifier
20047787
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.
Results Reference
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Effects of CPR Coaching on Leader's Performance During Simulated Cardiac Arrest

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