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

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT04778488
Collaborator
Municipal Ambulance Service, Vienna, Austria (Other)
300
Enrollment
1
Location
1
Arm
22.9
Anticipated Duration (Months)
13.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Near-Infrared-Spectroscopy (NIRS)
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Observational cohort study.Observational cohort study.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Messung Der Cerebralen Sauerstoffsättigung Mitttels Near-Infrared Spectooxymetrie in Der Reanimation Und Postreanimationsbehandlung
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: NIRS diagnostics

NIRS measurement

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

Outcome Measures

Primary Outcome Measures

  1. near-infrared-spectroscopy [minute 0]

    rSO2

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 18 years of age

  • out-of-hospital cardiac arrest

Exclusion Criteria:
  • <18 years of age

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna
  • Municipal Ambulance Service, Vienna, Austria

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sebastian Schnaubelt, MD, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT04778488
Other Study ID Numbers:
  • MUV_VINIRSCA
First Posted:
Mar 3, 2021
Last Update Posted:
Mar 3, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sebastian Schnaubelt, MD, Principal Investigator, Medical University of Vienna
NIRS
cardiac arrest
Additional relevant MeSH terms:
Heart Arrest

Study Results

No Results Posted as of Mar 3, 2021