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Comparison of the Quality of CPR by Professional Helpers (Emergency Physicians / Paramedics) During Flights (flights)

Primary Purpose

Cardiac Arrest

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
transport
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:

  • emergency physician
  • paramedic
  • > 18 years
  • < 60 years

Exclusion Criteria:

  • pregnant
  • lay rescuers

Sites / Locations

  • Uniklinik KölnRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Transport

Arm Description

10 minutes ALS-CPR in a normal environment

10 minutes ALS-CPR during a transport

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 10 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

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.

Full Information

First Posted
November 29, 2013
Last Updated
May 2, 2015
Sponsor
University Hospital of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT02002481
Brief Title
Comparison of the Quality of CPR by Professional Helpers (Emergency Physicians / Paramedics) During Flights
Acronym
flights
Official Title
Vergleich Der Qualität Der Kardiopulmonalen Reanimation Durch Professioneller Helfer (Notärzte / Rettungsassistenten) während Lufttransporten
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
December 2015 (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
Investigation of the influence of narrowness and unusual circumstances on the CPR-quality
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.

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
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
10 minutes ALS-CPR in a normal environment
Arm Title
Transport
Arm Type
Experimental
Arm Description
10 minutes ALS-CPR during a transport
Intervention Type
Other
Intervention Name(s)
transport
Intervention Description
The manikin will be resuscitated during a transport in a vessel by a professional team (emergency physician / paramedic).
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 10 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 10 minutes
Secondary Outcome Measure Information:
Title
Now-flow-time
Description
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.
Time Frame
after 10 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: emergency physician paramedic > 18 years < 60 years Exclusion Criteria: pregnant lay rescuers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Braunecker, MD
Phone
0221-478-97729
Email
stefan.braunecker@uk-koeln.de
First Name & Middle Initial & Last Name or Official Title & Degree
Jochen Hinkelbein, MD
Phone
0221-478-97729
Email
jochen.hinkelbein@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
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Hilgers, MD
Organizational Affiliation
University Hospital Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniklinik Köln
City
Köln
State/Province
NRW
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
Phone
0221-478-97729
Email
jochen.hinkelbein@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Stefan Braunecker, MD
First Name & Middle Initial & Last Name & Degree
Jochen Hinkelbein, MD
First Name & Middle Initial & Last Name & Degree
Jan Hilgers, MD

12. IPD Sharing Statement

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Comparison of the Quality of CPR by Professional Helpers (Emergency Physicians / Paramedics) During Flights

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