Effectiveness of Pediatric Resuscitation (EPR)

November 2, 2014 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education

Quality of Chest Compressions During 8 Min of Single-rescuer Pediatric Cardiopulmonary Resuscitation With Five Different CPR Feedback Devices. Randomised Crossover Manikin Trial

The aim of this study was to compare five CPR feedback devices to standard BLS in terms of the quality of single rescuer pediatric resuscitation. Therefore, the investigators hypothesis was that there would be no difference between CPR methods in terms of chest compression quality parameters.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Cardiac arrest is a leading cause of death worldwide. High-quality chest compressions are of paramount importance for survival and good neurological outcome. Unfortunately, even health professionals have difficulty performing effective CPR. Chest compression (CC) is often too shallow, compression ratio is inadequate, and hands-off time is too long. CPR feedback devices might be an option for rescuers to in order to increase CC efficiency.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Masovia
      • Warsaw, Masovia, Poland, 03-122
        • Recruiting
        • International Institute of Rescue Research and Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • give voluntary consent to participate in the study
  • medical profession (paramedics, nurses, physicians) or medical students (nurses, paramedics, physicians)

Exclusion Criteria:

  • not meet the above criteria
  • wrist or low back diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With feedback
Participants compress the chest of the manikin with CPR feedback device.
Device: Standard BLS
Standard basic life support = chest compressions without any feedback device (manual resuscitation)
Device: Standard BLS
Chest compressions without CPR feedback device (manual resuscitation)
Experimental: Without feedback
Participants compress the chest of the manikin without CPR feedback device
Device: Standard BLS
Standard basic life support = chest compressions without any feedback device (manual resuscitation)
Device: Standard BLS
Chest compressions without CPR feedback device (manual resuscitation)
Device: The CPRmeter
Feedback device - 1
Device: The PocketCPR
Feedback device - 2
Device: The CPREazy
Feedback device - 3
Device: The CPR PRO APP
Feedback device - 4
Device: The CardioPump
Feedback devices - 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective compressions was defined as compression with correct depth (40-50mm), correct hand position and complete decompressions
Time Frame: 1 month
effective compressions was defined as compression with correct depth (40-50mm), correct hand position and complete decompressions
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest compression depth
Time Frame: 1 month
To measure chest compression depth during 8 minutes. Chest compression depth will be measured using the software connected to the manikin and computer
1 month
Chest compression rate
Time Frame: 1 month
To measure the chest compression rate during 8 minutes. Chest compression rate will be measured using the software connected to the manikin and computer
1 month
effective compressions ratio was defined as effective compressions [%] multiplied by flow time [%]
Time Frame: 1 month
effective compressions ratio was defined as effective compressions [%] multiplied by flow time [%]
1 month
Flow time was defined as the sum of all periods during which chest compressions were performed
Time Frame: 1 month
flow time was defined as the sum of all periods during which chest compressions were performed.
1 month
absolute hands-off time was defined as the sum of all periods without chest compressions or ventilation
Time Frame: 1 month
absolute hands-off time (HOT) was defined as the sum of all periods without chest compressions or ventilation
1 month
VAS (visual analogue scale)
Time Frame: 1 month
after having completed the 8 min testing period, the study participants were asked how challenging they had experienced standard BLS or resuscitation which the respective feedback device. answers were rated on a 10-point Lickert scale (most difficult = 1 to easiest = 10)
1 month
Prefered CPR device
Time Frame: 1 month
after having completed the 8 min testing period, the study participants were asked how chellenging whitch method they would preferred. answers were rated on a 10-point Lickert scale (lower preferred = 1 to most preferred = 10)
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Institute of Rescue Research and Education

Investigators

  • Principal Investigator: Andrzej Kurowski, Institute of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

November 1, 2014

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

November 2, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 2, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPR/2014/06

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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