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Pediatric Resuscitation With Feedback Devices (CPR_NURSE)

Primary Purpose

Cardiac Arrest

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Standard BLS
The CPREazy
TrueCPR
The CPR PRO APP
The CardioPump
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 (nurses)

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

Without feedback

With feedback

Arm Description

Participants compress the chest of the manikin without CPR feedback device

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

Outcomes

Primary Outcome Measures

Effective compressions
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
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
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
November 16, 2014
Last Updated
November 16, 2014
Sponsor
International Institute of Rescue Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT02294721
Brief Title
Pediatric Resuscitation With Feedback Devices
Acronym
CPR_NURSE
Official Title
Quality of Pediatric Chest Compression: Comparing Four CPR Feedback Devices With Standard BLS by a Single Rescuer: A Randomised Controlled Manikin Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 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 four different 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
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Without feedback
Arm Type
Experimental
Arm Description
Participants compress the chest of the manikin without CPR feedback device
Arm Title
With feedback
Arm Type
Experimental
Arm Description
Participants compress the chest of the manikin with CPR feedback device.
Intervention Type
Device
Intervention Name(s)
Standard BLS
Intervention Description
Resuscitation without feedback devices, standard manual standard basic life support
Intervention Type
Device
Intervention Name(s)
The CPREazy
Intervention Description
feedback device-1
Intervention Type
Device
Intervention Name(s)
TrueCPR
Intervention Description
feedback device -2
Intervention Type
Device
Intervention Name(s)
The CPR PRO APP
Intervention Description
feedback device -3
Intervention Type
Device
Intervention Name(s)
The CardioPump
Intervention Description
feedback device- 4
Primary Outcome Measure Information:
Title
Effective compressions
Description
Effective compressions was defined as compression with correct depth (40-50mm), correct hand position and complete decompressions
Time Frame
1 day
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 day
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 day
Title
effective compressions ratio
Description
effective compressions ratio was defined as effective compressions [%] multiplied by flow time [%]
Time Frame
1day
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 day
Title
absolute hands-off time
Description
absolute hands-off time (HOT) was defined as the sum of all periods without chest compressions or ventilation
Time Frame
1 day
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 day
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 day

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 (nurses) 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
Andrzej Kurowski
Phone
+48500186225
Email
andrzejkurowski987@gmail.com
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
First Name & Middle Initial & Last Name & Degree
Andrzej Kurowski
First Name & Middle Initial & Last Name & Degree
Lukasz Czyżewski

12. IPD Sharing Statement

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Pediatric Resuscitation With Feedback Devices

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