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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02000505
Other study ID # 10-333
Secondary ID
Status Recruiting
Phase N/A
First received November 17, 2013
Last updated May 2, 2015
Start date November 2013
Est. completion date February 2016

Study information

Verified date May 2015
Source University Hospital of Cologne
Contact Stefan Braunecker, MD
Email stefan.braunecker@uk-koeln.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

Comparison of various methods to improve the quality of CPR


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date February 2016
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- lay rescuers

- >18 years

- <60 years

Exclusion Criteria:

- professional rescuers

- pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
PocketCPR
5 minutes chest-compression-only CPR, using Zoll PocketCPR
Metronome
5 minutes chest-compression-only CPR, using a metronome
110bpm Song
5 minutes chest-compression-only CPR, using a song with 110bpm for support

Locations

Country Name City State
Germany Uniklinik Köln Köln

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. after 5 minutes No
Secondary 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. after 5 minutes No
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