- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02000505
Comparison of the Quality of CPR by Lay Rescuers With and Without Feedback Devices (frequenz)
Comparison of the Quality of CPR by Lay Rescuers With and Without Telephone Instructions by a Simulated Rescue Coordination Center
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Köln, Germany, 50937
- Recruiting
- Uniklinik Koln
-
Principal Investigator:
- Jochen Hinkelbein, MD
-
Contact:
- Stefan Braunecker, MD
- Phone Number: 0221-478-97729
- Email: stefan.braunecker@uk-koeln.de
-
Principal Investigator:
- Stefan Braunecker, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- lay rescuers
- >18 years
- <60 years
Exclusion Criteria:
- professional rescuers
- pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
5 minutes chest-compression-only CPR, without any support
|
|
|
Experimental: PocketCPR
5 minutes chest-compression-only CPR, with support
|
5 minutes chest-compression-only CPR, using Zoll PocketCPR
|
|
Experimental: Metronome
5 minutes chest-compression-only CPR, with support
|
5 minutes chest-compression-only CPR, using a metronome
|
|
Experimental: 110bpm Song
5 minutes chest-compression-only CPR, with support
|
5 minutes chest-compression-only CPR, using a song with 110bpm for support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The average achieved cardiac output
Time Frame: after 5 minutes
|
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.
|
after 5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Constancy of the quality of chest-compressions
Time Frame: after 5 minutes
|
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.
|
after 5 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stefan Braunecker, MD, University Hospital Cologne
- Study Director: Jochen Hinkelbein, MD, University Hospital Cologne
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-333
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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