Out-of-hospital Cardiopulmonary Resuscitation and AED Feedback
Primary Purpose
Cardiac Arrest, Resuscitation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Zoll AED pro
Zoll AED pro
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Arrest focused on measuring AED (automated external defibrillation), feedback, out of hospital resuscitation
Eligibility Criteria
Inclusion Criteria:
- cardiac arrest
Exclusion Criteria:
- age under 18 years
Sites / Locations
- Department of Anesthesiology and Intensive Care, University Hospital Muenster
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1. Extended feedback
2. Limited feedback
Arm Description
Outcomes
Primary Outcome Measures
ratio of patients with spontaneous circulation
Secondary Outcome Measures
length of hospital stay
neurological status
neurological status
Full Information
NCT ID
NCT00449969
First Posted
March 20, 2007
Last Updated
April 21, 2011
Sponsor
University Hospital Muenster
1. Study Identification
Unique Protocol Identification Number
NCT00449969
Brief Title
Out-of-hospital Cardiopulmonary Resuscitation and AED Feedback
Official Title
Quality of Out-of-hospital Cardiopulmonary Resuscitation (CPR) With Real Time Automated Feedback: a Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Muenster
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether an online automatic feedback improved CPR quality (No-flow time, compression depth, short-term survival and one year follow up) in this prospective randomised study of out-of-hospital cardiac arrest
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Resuscitation
Keywords
AED (automated external defibrillation), feedback, out of hospital resuscitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
312 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. Extended feedback
Arm Type
Experimental
Arm Title
2. Limited feedback
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Zoll AED pro
Intervention Description
Arm one (Extended feedback) offers full feedback guidance during CPR
Intervention Type
Device
Intervention Name(s)
Zoll AED pro
Intervention Description
In arm two (limited feedback) feedback is modified lacking several elements of feedback
Primary Outcome Measure Information:
Title
ratio of patients with spontaneous circulation
Time Frame
admission to the hospital
Secondary Outcome Measure Information:
Title
length of hospital stay
Time Frame
hospital discharge
Title
neurological status
Time Frame
hospital discharge
Title
neurological status
Time Frame
one year after resuscitation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cardiac arrest
Exclusion Criteria:
age under 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas P Weber, MD
Organizational Affiliation
Department of Anesthesiology and Intensive Care, University Hospital Muenster
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anesthesiology and Intensive Care, University Hospital Muenster
City
Muenster
ZIP/Postal Code
D-48149
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
20151103
Citation
Lukas RP, Sengelhoff C, Dopker S, Harding U, Mertens P, Osada N, Van Aken H, Weber TP, Bohn A. [Chest compression quality : Can feedback technology help?]. Anaesthesist. 2010 Feb;59(2):135-9. doi: 10.1007/s00101-009-1671-4. German.
Results Reference
result
PubMed Identifier
21146279
Citation
Bohn A, Weber TP, Wecker S, Harding U, Osada N, Van Aken H, Lukas RP. The addition of voice prompts to audiovisual feedback and debriefing does not modify CPR quality or outcomes in out of hospital cardiac arrest--a prospective, randomized trial. Resuscitation. 2011 Mar;82(3):257-62. doi: 10.1016/j.resuscitation.2010.11.006. Epub 2010 Dec 13.
Results Reference
result
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Out-of-hospital Cardiopulmonary Resuscitation and AED Feedback
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