NCT04778488

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

4.8 years

First QC Date

February 23, 2021

Last Update Submit

April 5, 2025

Conditions

Keywords

NIRScardiac arrest

Outcome Measures

Primary Outcomes (1)

  • near-infrared-spectroscopy

    rSO2

    minute 0

Study Arms (1)

NIRS diagnostics

OTHER

NIRS measurement

Device: Near-Infrared-Spectroscopy (NIRS)

Interventions

Placement of 2 NIRS optodes on the patients' forehead, measurement of NIRS during cardiac arrest and up to 72h post return of spontaneous circulation

NIRS diagnostics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \<18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related 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.

    PMID: 29410191BACKGROUND
  • 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.

    PMID: 31513863BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Observational cohort study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2021

First Posted

March 3, 2021

Study Start

May 1, 2017

Primary Completion

March 1, 2022

Study Completion

October 31, 2022

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Data can be shared upon reasonable request after assessing and analysing.

Locations