Pre-Hospital Cerebral Oxygenation and End-Tidal CO2 During Cardiopulmonary Resuscitation (CPR)

out-of Hospital Cardiac Arrest Clinical Trial

— CopernicusIb  

Official title:

Pre-Hospital Cerebral Oxygenation and End-Tidal CO2 During Cardiopulmonary Resuscitation (CPR)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02850237
• Other study ID #: CopernicusIb
• Status: Recruiting
• Phase: N/A
• First received: April 20, 2016
• Last updated: July 27, 2016
• Start date: April 2016
• Est. completion date: September 2016

Study information

• Verified date: July 2016
• Source: Hasselt University
• Contact: Cornelia Genbrugge, MD
• Phone: 003289325359
• Email: cornelia.genbrugge[@]uhasselt.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• all consecutive OHCA patients

Exclusion Criteria:

• DNR code

• no possibility to attach cerebral oxygenation sensor

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Arrest
• out-of Hospital Cardiac Arrest
• Out-of-Hospital Cardiac Arrest

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No