NCT02850237

Brief Summary

Cerebral saturation will be measured pre-hospital during an out-of hospital cardiac arrest with O3TM regional oximetry for Root® (Masimo®). The O3TM regional oximetry for Root® (Masimo®) is a device that can measure not only cerebral saturation but also end-tidal CO2 (capnography). Currently, end-tidal CO2 is already measured during Advanced Life Support following most recent European Resuscitation Guidelines but with another monitor. Until now it is the only parameter which may predict return of spontaneous circulation. Because of this, researchers want to measure both with the same device, which gives the investigators the opportunity and advantage to compare end-tidal CO2 and cerebral saturation very precisely. In this manner researchers want to investigate the predictive value of cerebral saturation and compare it end-tidal CO2.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

5 months

First QC Date

April 20, 2016

Last Update Submit

July 27, 2016

Conditions

out-of Hospital Cardiac Arrest

Keywords

cerebral saturationcapnographypre-hospital

Outcome Measures

Primary Outcomes (1)

  • Clinical parameter: return of spontaneous circulation (ROSC) by pulse check

    Difference between regional cerebral saturation and end-tidal carbon dioxide in detecting return of spontaneous circulation

    when ROSC occurs, within 1 day

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:

  • all consecutive OHCA patients

You may not qualify if:

  • DNR code
  • no possibility to attach cerebral oxygenation sensor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Central Study Contacts

Cornelia Genbrugge, MD

CONTACT

003289325359cornelia.genbrugge@uhasselt.be

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 20, 2016

First Posted

July 29, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations

BE(1)