Prehospital Cerebral Oxygenation During Cardiopulmonary R... | NCT01806844

Studies
Prehospital Cerebral Oxygenation During Cardiopulmonary Resuscitation (CPR)

NCT01806844

Sponsor

Hasselt University

Status

Completed

Last Update Posted

Apr 21, 2016Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Cardiac Arrest

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Mar 6, 2013

First Submission Date that Met QC Criteria

Mar 6, 2013

First Posted Date

Mar 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2016

Last Update Posted Date

Apr 21, 2016Estimated

Name	Class
Ziekenhuis Oost-Limburg	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prognostic value	Prognostic value of cerebral oxygenation during CPR	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>16 year

Exclusion Criteria:

DNR code

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

pre-hospital cardiac arrest

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cornelia Genbrugge, MD	Hasselt University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ziekenhuis netwerk Antwerpen		Antwerp	Antwerpen	2000	Belgium
Ziekenhuis Oost-Limburg

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23448653	Background	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.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases