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Pediatric Resuscitation With Feedback CPR Devices (PRFD)

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
The TrueCPR feedback device
Standard BLS
Sponsored by
International Institute of Rescue Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • International Institute of Rescue Research and Education

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chest compression of manikins chest

Arm Description

Compression of pediatric manikins chest according European Resuscitation Council 2010 guidelines for cardiopulmonary resuscitation.

Outcomes

Primary Outcome Measures

Effective compressions compression with correct depth (40-50mm), correct hand position and complete decompressions
effective compressions was defined as compression with correct depth (40-50mm), correct hand position and complete decompressions

Secondary Outcome Measures

effective compressions ratio effective compressions [%] multiplied by flow time [%]
effective compressions ratio was defined as effective compressions [%] multiplied by flow time [%]
Flow time sum of all periods during which chest compressions were performed.
flow time was defined as the sum of all periods during which chest compressions were performed.
absolute hands-off time sum of all periods without chest compressions or ventilation
absolute hands-off time (HOT) was defined as the sum of all periods without chest compressions or ventilation
Compression depth compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer
compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer

Full Information

First Posted
October 30, 2014
Last Updated
November 15, 2014
Sponsor
International Institute of Rescue Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT02281903
Brief Title
Pediatric Resuscitation With Feedback CPR Devices
Acronym
PRFD
Official Title
Is Chest Compressions Using the TrueCPRTM Feedback Device More Effective Than Manual Compressions During Pediatric Resuscitation? A Manikin Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Institute of Rescue Research and Education

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study was to compare the TrueCPR feedback device (with metronome) to standard basic life support (BLS) in terms of the quality of single rescuer pediatric resuscitation. Therefore, our hypothesis was that there would be no difference between both CPR methods in terms of chest compression quality parameters.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chest compression of manikins chest
Arm Type
Experimental
Arm Description
Compression of pediatric manikins chest according European Resuscitation Council 2010 guidelines for cardiopulmonary resuscitation.
Intervention Type
Device
Intervention Name(s)
The TrueCPR feedback device
Intervention Description
feedback devices
Intervention Type
Device
Intervention Name(s)
Standard BLS
Intervention Description
Standard basic life support = chest compressions without any feedback device (manual resuscitation)
Primary Outcome Measure Information:
Title
Effective compressions compression with correct depth (40-50mm), correct hand position and complete decompressions
Description
effective compressions was defined as compression with correct depth (40-50mm), correct hand position and complete decompressions
Time Frame
1 month
Secondary Outcome Measure Information:
Title
effective compressions ratio effective compressions [%] multiplied by flow time [%]
Description
effective compressions ratio was defined as effective compressions [%] multiplied by flow time [%]
Time Frame
1 month
Title
Flow time sum of all periods during which chest compressions were performed.
Description
flow time was defined as the sum of all periods during which chest compressions were performed.
Time Frame
1 month
Title
absolute hands-off time sum of all periods without chest compressions or ventilation
Description
absolute hands-off time (HOT) was defined as the sum of all periods without chest compressions or ventilation
Time Frame
1 month
Title
Compression depth compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer
Description
compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
Organizational Affiliation
Institute of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Institute of Rescue Research and Education
City
Warsaw
State/Province
Masovia
ZIP/Postal Code
03-122
Country
Poland

12. IPD Sharing Statement

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Pediatric Resuscitation With Feedback CPR Devices

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