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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02002481
Other study ID # 11-289
Secondary ID
Status Recruiting
Phase N/A
First received November 29, 2013
Last updated May 2, 2015
Start date December 2013
Est. completion date December 2015

Study information

Verified date May 2015
Source University Hospital of Cologne
Contact Stefan Braunecker, MD
Phone 0221-478-97729
Email stefan.braunecker@uk-koeln.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

Investigation of the influence of narrowness and unusual circumstances on the CPR-quality


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 under normal ambient conditions. Especially the mean frequenices of cardiac compression varies from 60 to 160/min, as well as the now-flow-time. Aim of this study is to investigate how narrowness and movement during a transport affect the CPR-performance.

For this, we examine the impact of the common transport options (air and ground) on the outcome-varity on a manikin. The subjects for this study are professional rescuers (emergency physicians / paramedics) who perform a 10 minute ALS-CPR in either normal circumstances (resuscitation-room) or during transportation.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- emergency physician

- paramedic

- > 18 years

- < 60 years

Exclusion Criteria:

- pregnant

- lay rescuers

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
transport
The manikin will be resuscitated during a transport in a vessel by a professional team (emergency physician / paramedic).

Locations

Country Name City State
Germany Uniklinik Köln Köln NRW

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 10 min manikin-resuscitation. The thus obtained average cardiac-output (CO = CR x CD), measured in [mm/min], will be compared in each group. after 10 minutes No
Secondary Now-flow-time Second objective of the study is the time without chest-compression during the 10 minutes ALS-CPR. The now-flow-time is read out of the recorded manikin-data specify, in [min] and [sec]. As a result, the average now-flow-time in each group will be calculated and compared for each group. after 10 minutes No
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