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

Primary Purpose

Cardiac Arrest

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Near-Infrared-Spectroscopy (NIRS)
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Arrest focused on measuring NIRS, cardiac arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >18 years of age
  • out-of-hospital cardiac arrest

Exclusion Criteria:

  • <18 years of age

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

NIRS diagnostics

Arm Description

NIRS measurement

Outcomes

Primary Outcome Measures

near-infrared-spectroscopy
rSO2

Secondary Outcome Measures

Full Information

First Posted
February 23, 2021
Last Updated
February 26, 2021
Sponsor
Medical University of Vienna
Collaborators
Municipal Ambulance Service, Vienna, Austria
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1. Study Identification

Unique Protocol Identification Number
NCT04778488
Brief Title
Vienna Near-Infrared Spectroscopy in Cardiac Arrest Study (VINIRSCA)
Acronym
VINIRSCA
Official Title
Messung Der Cerebralen Sauerstoffsättigung Mitttels Near-Infrared Spectooxymetrie in Der Reanimation Und Postreanimationsbehandlung
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
Municipal Ambulance Service, Vienna, Austria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
NIRS, cardiac arrest

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Observational cohort study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NIRS diagnostics
Arm Type
Other
Arm Description
NIRS measurement
Intervention Type
Device
Intervention Name(s)
Near-Infrared-Spectroscopy (NIRS)
Intervention Description
Placement of 2 NIRS optodes on the patients' forehead, measurement of NIRS during cardiac arrest and up to 72h post return of spontaneous circulation
Primary Outcome Measure Information:
Title
near-infrared-spectroscopy
Description
rSO2
Time Frame
minute 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >18 years of age out-of-hospital cardiac arrest Exclusion Criteria: <18 years of age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Schnaubelt, MD
Phone
++4314040019640
Email
sebastian.schnaubelt@muv.ac.at
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Schnaubelt, MD
Phone
++4314040019640

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data can be shared upon reasonable request after assessing and analysing.
Citations:
PubMed Identifier
29410191
Citation
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.
Results Reference
background
PubMed Identifier
31513863
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. No abstract available.
Results Reference
background

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

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