- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02002481
Comparison of the Quality of CPR by Professional Helpers (Emergency Physicians / Paramedics) During Flights (flights)
Vergleich Der Qualität Der Kardiopulmonalen Reanimation Durch Professioneller Helfer (Notärzte / Rettungsassistenten) während Lufttransporten
Study Overview
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 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
NRW
-
Köln, NRW, Germany, 50937
- Recruiting
- Uniklinik Köln
-
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
-
Contact:
- Phone Number: 0221-478-97729
- Email: jochen.hinkelbein@uk-koeln.de
-
Principal Investigator:
- Jan Hilgers, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- emergency physician
- paramedic
- > 18 years
- < 60 years
Exclusion Criteria:
- pregnant
- lay rescuers
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
10 minutes ALS-CPR in a normal environment
|
|
|
Experimental: Transport
10 minutes ALS-CPR during a transport
|
The manikin will be resuscitated during a transport in a vessel by a professional team (emergency physician / paramedic).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The average achieved cardiac output
Time Frame: after 10 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 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Now-flow-time
Time Frame: after 10 minutes
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stefan Braunecker, MD, University Hospital Cologne
- Principal Investigator: Jochen Hinkelbein, MD, University Hospital Cologne
- Principal Investigator: Jan Hilgers, 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
- 11-289
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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