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Effectiveness of Pediatric Resuscitation (EPR)

Primary Purpose

Cardiac Arrest

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
The CPRmeter
The PocketCPR
Standard BLS
The CPREazy
The CPR PRO APP
The CardioPump
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 EducationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

With feedback

Without feedback

Arm Description

Participants compress the chest of the manikin with CPR feedback device.

Participants compress the chest of the manikin without CPR feedback device

Outcomes

Primary Outcome Measures

Effective compressions was defined as 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

Chest compression depth
To measure chest compression depth during 8 minutes. Chest compression depth will be measured using the software connected to the manikin and computer
Chest compression rate
To measure the chest compression rate during 8 minutes. Chest compression rate will be measured using the software connected to the manikin and computer
effective compressions ratio was defined as effective compressions [%] multiplied by flow time [%]
effective compressions ratio was defined as effective compressions [%] multiplied by flow time [%]
Flow time was defined as the 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 was defined as the 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
VAS (visual analogue scale)
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)
Prefered CPR device
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)

Full Information

First Posted
October 30, 2014
Last Updated
November 2, 2014
Sponsor
International Institute of Rescue Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT02283034
Brief Title
Effectiveness of Pediatric Resuscitation
Acronym
EPR
Official Title
Quality of Chest Compressions During 8 Min of Single-rescuer Pediatric Cardiopulmonary Resuscitation With Five Different CPR Feedback Devices. Randomised Crossover Manikin Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

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 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.
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
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
With feedback
Arm Type
Experimental
Arm Description
Participants compress the chest of the manikin with CPR feedback device.
Arm Title
Without feedback
Arm Type
Experimental
Arm Description
Participants compress the chest of the manikin without CPR feedback device
Intervention Type
Device
Intervention Name(s)
The CPRmeter
Intervention Description
Feedback device - 1
Intervention Type
Device
Intervention Name(s)
The PocketCPR
Intervention Description
Feedback device - 2
Intervention Type
Device
Intervention Name(s)
Standard BLS
Intervention Description
Standard basic life support = chest compressions without any feedback device (manual resuscitation)
Intervention Type
Device
Intervention Name(s)
The CPREazy
Intervention Description
Feedback device - 3
Intervention Type
Device
Intervention Name(s)
The CPR PRO APP
Intervention Description
Feedback device - 4
Intervention Type
Device
Intervention Name(s)
The CardioPump
Intervention Description
Feedback devices - 5
Intervention Type
Device
Intervention Name(s)
Standard BLS
Intervention Description
Chest compressions without CPR feedback device (manual resuscitation)
Primary Outcome Measure Information:
Title
Effective compressions was defined as 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
Chest compression depth
Description
To measure chest compression depth during 8 minutes. Chest compression depth will be measured using the software connected to the manikin and computer
Time Frame
1 month
Title
Chest compression rate
Description
To measure the chest compression rate during 8 minutes. Chest compression rate will be measured using the software connected to the manikin and computer
Time Frame
1 month
Title
effective compressions ratio was defined as 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 was defined as the 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 was defined as the 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
VAS (visual analogue scale)
Description
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)
Time Frame
1 month
Title
Prefered CPR device
Description
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)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lukasz Szarpak
Phone
+48500186225
Email
lukasz.szarpak@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrzej Kurowski
Organizational Affiliation
Institute of Cardiology
Official's Role
Principal Investigator
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
Phone
+48500186225
Email
lukasz.szarpak@gmail.com

12. IPD Sharing Statement

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Effectiveness of Pediatric Resuscitation

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