NCT01361919

Brief Summary

The goal of this study is to compare three methods of teaching medical and nursing students basic life saving skills. The standard method will teach students how to push on the chest and to analyze the heart rhythm using a regular monitor. The newer approach will teach the same skills but use a special heart monitor that provides both visual and verbal reminders. The third approach will combine both the standard and newer approaches to teaching. Our study would like to find out the better way to teach these skills and to create a standard way to grade how well students perform. This study will measure how deep and how fast the students push on the manikin's chest in a certain amount of time. Other goals include measuring how well the students use the heart monitor to deliver shocks and analyze the heart rhythm, how many breaths per minute they give, how long their hands are off the manikin and how well they think they performed overall.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2010

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
9 months until next milestone

First Posted

Study publicly available on registry

May 27, 2011

Completed
8.1 years until next milestone

Results Posted

Study results publicly available

July 15, 2019

Completed
Last Updated

July 15, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

August 3, 2010

Results QC Date

April 27, 2017

Last Update Submit

May 1, 2019

Conditions

Keywords

compressionsqualityteaching methodfeedbackCPR performanceCardiopulmonary resuscitation (CPR)

Outcome Measures

Primary Outcomes (2)

  • CPR Depth

    Depth of chest compressions measured in millimeters

    baseline

  • CPR Rate

    rate of chest compression per minute

    baseline

Secondary Outcomes (1)

  • Ventilations

    baseline

Study Arms (3)

Feedback During CPR Training and Testing

EXPERIMENTAL

A "feedback" defibrillator (ZOLL R series) will be used at teaching, immediate testing and 12 week (retention) testing. A simulation manikin with an attached accelerometer pad on its sternum will be used to collect CPR performance data. Subjects will be told to perform compressions on top of the accelerometer pad and will be taught to use and follow the audio and visual feedback to optimize their CPR performance. After training, the raw data collected by the accelerometer will be used as a demonstration and training tool, to correct the subjects' performance by visually demonstrating the difference between ideal and suboptimal CPR performance. Testing will be carried out with the use of a "feedback" defibrillator.

Procedure: Feedback During CPR Training and TestingProcedure: Feedback during CPR Training Not Testing

Feedback during CPR Training Not Testing

ACTIVE COMPARATOR

A "feedback" defibrillator will be used for teaching, with a standard no "feedback" defibrillator used at immediate and 12 week (retention) testing to assess if the techniques the students' learned during training are transferable to devices without "feedback". In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest.

Procedure: Feedback During CPR Training and Testing

No Feedback Group

PLACEBO COMPARATOR

A standard no "feedback" defibrillator (ZOLL M series) will be used for teaching, immediate testing and 12 week (retention) testing. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. During the test, subjects will be informed that data on their performance will be recorded but they will not be told how this will occur.

Procedure: No Feedback Group

Interventions

Students in this group will receive training in BLS skills according to the 2005 AHA/ILCOR guidelines, using the ZOLL R Series™ defibrillator with an attached accelerometer pad that will be placed on the sternum of the manikin and visible to the user. Participants will be taught to use and follow the audio and visual feedback provided by the accelerometer and defibrillator to optimize their CPR performance (depth, rate, and minimal "hands-off" time). After the simulated cardiac arrest scenario, a data card containing the raw data collected from the accelerometer and defibrillator will be downloaded onto a laptop and used as a demonstration and training tool.

Feedback During CPR Training and TestingFeedback during CPR Training Not Testing

A standard no "feedback" defibrillator (ZOLL M series) will be used for teaching, immediate testing and 12 week (retention) testing. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. During the test, subjects will be informed that data on their performance will be recorded but they will not be told how this will occur.

Also known as: simulation CPR training
No Feedback Group

Students in this group will be tested using a five minute basic vfib arrest scenario and an R-series defibrillator and told to perform compressions on top of the accelerometer pad. The hexagonal icon will be visible but no prompting on its usage will be delivered during testing.

Also known as: Feedback during simulation testing
Feedback During CPR Training and Testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • medical or nursing students aged \>= 18

You may not qualify if:

  • unwilling to sign consent, or
  • unable to return in 3 months time for follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Limitations and Caveats

Participants' resuscitation skills were not assessed prior to providing training. The study was conducted in a simulation environment and performance in a real cardiac arrest would need to be assessed to determine the true impact of our intervention.

Results Point of Contact

Title
Dr. Paul Dorian
Organization
St. Michael's Hospital

Study Officials

  • Paul Dorian, MD, FRCPC

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR
  • Natalie Wong, MD, FRCPC

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2010

First Posted

May 27, 2011

Study Start

September 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2010

Last Updated

July 15, 2019

Results First Posted

July 15, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

No sharing is planned

Locations