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Comparison of the Quality of CPR by Lay Rescuers With and Without Feedback Devices (frequenz)

Primary Purpose

Cardiac Arrest

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
PocketCPR
Metronome
110bpm Song
Sponsored by
University Hospital of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • lay rescuers
  • >18 years
  • <60 years

Exclusion Criteria:

  • professional rescuers
  • pregnancy

Sites / Locations

  • Uniklinik KölnRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

PocketCPR

Metronome

110bpm Song

Arm Description

5 minutes chest-compression-only CPR, without any support

5 minutes chest-compression-only CPR, with support

5 minutes chest-compression-only CPR, with support

5 minutes chest-compression-only CPR, with support

Outcomes

Primary Outcome Measures

The average achieved cardiac output
The main goal of the study is the average achieved cardiac output. Data acquisition is carried out on a resuscitation-manikin which can measure compression-rate (CR) and compression-depth (CD). The data are recorded by a computer during the CPR. To calculate the cardiac output, we multiply the average CR [1/min] with the average CD [mm] during the 5 min manikin-resuscitation. The thus obtained average cardiac-output (CO = CR x CD), measured in [mm/min], will be compared in each group.

Secondary Outcome Measures

Constancy of the quality of chest-compressions
Second objective of the study is the variation of the compression-rate and the compression-depth during the resuscitation. We compare the average compression-rate and compression-depth of the first 30 compressions and the last 30 compression of every participant. As a result, the average standard deviation in each group will be calculated. Afterward, the groups will be compared using the mean deviation of every group. The mean deviation will be measured in +/-[mm] for compression-depth and +/-[1/min] for compression rate.

Full Information

First Posted
November 17, 2013
Last Updated
May 2, 2015
Sponsor
University Hospital of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT02000505
Brief Title
Comparison of the Quality of CPR by Lay Rescuers With and Without Feedback Devices
Acronym
frequenz
Official Title
Comparison of the Quality of CPR by Lay Rescuers With and Without Telephone Instructions by a Simulated Rescue Coordination Center
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Cologne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparison of various methods to improve the quality of CPR
Detailed Description
Even for paramedics and emergency physicians, the resuscitation of patients with cardiac arrest remains a challenge. Previous studies have shown that the cardiac output varies widely even among professional helpers. This is especially due to some very different mean frequencies of cardiac compression wich vary from 60 to 160/min for paramedics. Aim of this study is to investigate whether the use of feedback-devices during cardiac-pulmonary resuscitation (CPR) can lead to an improvement of the cardiac output and may improve survival. For this, we examine the impact of different feedback-methods on the frequence-variety on manikin by lay rescuers. Overall, we compare three different devices for feedback during CPR. The subjects for this study are lay rescuers who perform a 5 minute chest-compression-only CPR.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
5 minutes chest-compression-only CPR, without any support
Arm Title
PocketCPR
Arm Type
Experimental
Arm Description
5 minutes chest-compression-only CPR, with support
Arm Title
Metronome
Arm Type
Experimental
Arm Description
5 minutes chest-compression-only CPR, with support
Arm Title
110bpm Song
Arm Type
Experimental
Arm Description
5 minutes chest-compression-only CPR, with support
Intervention Type
Device
Intervention Name(s)
PocketCPR
Intervention Description
5 minutes chest-compression-only CPR, using Zoll PocketCPR
Intervention Type
Device
Intervention Name(s)
Metronome
Intervention Description
5 minutes chest-compression-only CPR, using a metronome
Intervention Type
Device
Intervention Name(s)
110bpm Song
Intervention Description
5 minutes chest-compression-only CPR, using a song with 110bpm for support
Primary Outcome Measure Information:
Title
The average achieved cardiac output
Description
The main goal of the study is the average achieved cardiac output. Data acquisition is carried out on a resuscitation-manikin which can measure compression-rate (CR) and compression-depth (CD). The data are recorded by a computer during the CPR. To calculate the cardiac output, we multiply the average CR [1/min] with the average CD [mm] during the 5 min manikin-resuscitation. The thus obtained average cardiac-output (CO = CR x CD), measured in [mm/min], will be compared in each group.
Time Frame
after 5 minutes
Secondary Outcome Measure Information:
Title
Constancy of the quality of chest-compressions
Description
Second objective of the study is the variation of the compression-rate and the compression-depth during the resuscitation. We compare the average compression-rate and compression-depth of the first 30 compressions and the last 30 compression of every participant. As a result, the average standard deviation in each group will be calculated. Afterward, the groups will be compared using the mean deviation of every group. The mean deviation will be measured in +/-[mm] for compression-depth and +/-[1/min] for compression rate.
Time Frame
after 5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: lay rescuers >18 years <60 years Exclusion Criteria: professional rescuers pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Braunecker, MD
Email
stefan.braunecker@uk-koeln.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Braunecker, MD
Organizational Affiliation
University Hospital Cologne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jochen Hinkelbein, MD
Organizational Affiliation
University Hospital Cologne
Official's Role
Study Director
Facility Information:
Facility Name
Uniklinik Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Braunecker, MD
Phone
0221-478-97729
Email
stefan.braunecker@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Stefan Braunecker, MD
First Name & Middle Initial & Last Name & Degree
Jochen Hinkelbein, MD

12. IPD Sharing Statement

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Comparison of the Quality of CPR by Lay Rescuers With and Without Feedback Devices

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