NCT01806844

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Typical duration for all trials

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

March 6, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

2.5 years

First QC Date

March 6, 2013

Last Update Submit

April 19, 2016

Conditions

Cardiac Arrest

Keywords

Cardiac arrestCerebral oxygenationPre-hospital

Outcome Measures

Primary Outcomes (1)

  • prognostic value

    Prognostic value of cerebral oxygenation during CPR

    1 year

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pre-hospital cardiac arrest

You may qualify if:

  • \>16 year

You may not qualify if:

  • DNR code

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Ziekenhuis netwerk Antwerpen

Antwerp, Antwerpen, 2000, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Universitair ziekenhuis Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

GZA St Vincentius

Antwerp, Belgium

Location

AZ Turnhout

Turnhout, Belgium

Location

Related 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.

    PMID: 23448653BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Cornelia Genbrugge, MD

    Hasselt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Genbrugge

Study Record Dates

First Submitted

March 6, 2013

First Posted

March 7, 2013

Study Start

May 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

April 21, 2016

Record last verified: 2016-04

Locations

BE(5)