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NCT00449969 Clinical Trial

Out-of-hospital Cardiopulmonary Resuscitation and AED Feedback

Cardiac Arrest Clinical Trial

Official title:
Quality of Out-of-hospital Cardiopulmonary Resuscitation (CPR) With Real Time Automated Feedback: a Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00449969
Other study ID # 02-AnIt-07
Secondary ID
Status Completed
Phase N/A
First received March 20, 2007
Last updated April 21, 2011
Start date April 2007
Est. completion date December 2010

Study information
Verified date April 2011
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 312
Est. completion date December 2010
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- cardiac arrest

Exclusion Criteria:

- age under 18 years

Study Design

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

Related Conditions & MeSH terms

Intervention

Device:
• Zoll AED pro
Arm one (Extended feedback) offers full feedback guidance during CPR
• Zoll AED pro
In arm two (limited feedback) feedback is modified lacking several elements of feedback

Locations
Country Name City State
Germany Department of Anesthesiology and Intensive Care, University Hospital Muenster Muenster

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. Resuscit — View Citation

Lukas RP, Sengelhoff C, Döpker 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary ratio of patients with spontaneous circulation admission to the hospital No
Secondary length of hospital stay hospital discharge No
Secondary neurological status hospital discharge No
Secondary neurological status one year after resuscitation No
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