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NCT01806844 Clinical Trial

Prehospital Cerebral Oxygenation During Cardiopulmonary Resuscitation (CPR)

Cardiac Arrest Clinical Trial

Official title:
Cerebral Oxygenation During Resuscitation and Post-resuscitation Phase

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01806844
Other study ID # Copernicus I
Secondary ID
Status Completed
Phase N/A
First received March 6, 2013
Last updated April 19, 2016
Start date May 2013
Est. completion date November 2015

Study information
Verified date April 2016
Source Hasselt University
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational

Clinical Trial Summary

Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation in a non-invasive manner. Through the use of near infrared light, the difference between oxygenated and deoxygenated hemoglobin can be measured. By applying the Beer-Lamber law, a numeric result can be calculated. During a cardiac arrest, there is no stroke volume, no cardiac output and no cerebral perfusion. By using cerebral NIRS during out-of hospital cardiac arrest, low flow time and return of spontaneous circulation, this study wants to show the prognostic value of NIRS as extra monitoring.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- >16 year

Exclusion Criteria:

- DNR code

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium GZA St Vincentius Antwerp
Belgium Ziekenhuis netwerk Antwerpen Antwerpen
Belgium Ziekenhuis Oost-Limburg Genk Limburg
Belgium Universitair ziekenhuis Leuven Leuven Vlaams Brabant
Belgium AZ Turnhout Turnhout

Sponsors (2)
Lead Sponsor Collaborator
Hasselt University Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Meex I, De Deyne C, Dens J, Scheyltjens S, Lathouwers K, Boer W, Vundelinckx G, Heylen R, Jans F. Feasibility of absolute cerebral tissue oxygen saturation during cardiopulmonary resuscitation. Crit Care. 2013 Mar 1;17(2):R36. doi: 10.1186/cc12546. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary prognostic value Prognostic value of cerebral oxygenation during CPR 1 year No
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