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NCT04778488 Clinical Trial

Vienna Near-Infrared Spectroscopy in Cardiac Arrest Study (VINIRSCA)

Cardiac Arrest Clinical Trial

— VINIRSCA  

Official title:
Messung Der Cerebralen Sauerstoffsättigung Mitttels Near-Infrared Spectooxymetrie in Der Reanimation Und Postreanimationsbehandlung

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04778488
Other study ID # MUV_VINIRSCA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date December 31, 2022

Study information
Verified date February 2021
Source Medical University of Vienna
Contact Sebastian Schnaubelt, MD
Phone ++4314040019640
Email sebastian.schnaubelt@muv.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Measurement of Near-Infrared Spectroscopy (NIRS) during and after out-of-hospital cardiac arrest (OHCA) in the city of Vienna and the tertiary university hospital of the Medical University of Vienna, Austria. NIRS will be evaluated as a tool for resuscitation quality assessment as well as a prognosticator for cardiac arrest outcomes. Already-existing literature will be taken into account, and already-existing cutoffs and prognosticating values will be assessed and - if eligible - validated in a real-life setting.

Description:

Patients suffering from out-of-hospital cardiac arrest (OHCA) and receiving cardiopulmonary resuscitation (CPR) in terms of advanced life support (ALS) in the city of Vienna, Austria, will be included. A special study team will be dispatched to the event sites by the ambulance service. Trained study fellows will include patients by placing NIRS optodes on the patients' forehead as soon as possible during and/or after CPR. Measurements will continue until 72h post return of spontaneous circulation (ROSC) or the patient's death.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - >18 years of age - out-of-hospital cardiac arrest Exclusion Criteria: - <18 years of age

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Near-Infrared-Spectroscopy (NIRS)
Placement of 2 NIRS optodes on the patients' forehead, measurement of NIRS during cardiac arrest and up to 72h post return of spontaneous circulation

Locations
Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (2)
Lead Sponsor Collaborator
Medical University of Vienna Municipal Ambulance Service, Vienna, Austria

Country where clinical trial is conducted

Austria, 

References & Publications (2)

Schnaubelt S, Sulzgruber P, Menger J, Skhirtladze-Dworschak K, Sterz F, Dworschak M. Regional cerebral oxygen saturation during cardiopulmonary resuscitation as a predictor of return of spontaneous circulation and favourable neurological outcome - A review of the current literature. Resuscitation. 2018 Apr;125:39-47. doi: 10.1016/j.resuscitation.2018.01.028. Epub 2018 Feb 2. Review. — View Citation

Schnaubelt S, Uray T. The need for comprehensive NIRS-measurement from on-scene treatment to post-ROSC phase. Resuscitation. 2019 Nov;144:191-192. doi: 10.1016/j.resuscitation.2019.07.038. Epub 2019 Sep 9. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary near-infrared-spectroscopy rSO2 minute 0
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