Cerebral Oxymetry at Elective Coronary and Valve Surgery. | NCT01940874

Studies
Cerebral Oxymetry at Elective Coronary and Valve Surgery.

NCT01940874

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Oct 9, 2013Estimated

Enrollment

54Actual

Phase

Not provided

Conditions

Coronary Artery Disease.
Aortic Valve Stenosis.
Aortic Valve Regurgitation.

Interventions

Not provided

Countries

Norway

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

Oct 2013

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

Feb 2011

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Sep 9, 2013

First Submission Date that Met QC Criteria

Sep 9, 2013

First Posted Date

Sep 12, 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

Oct 8, 2013

Last Update Posted Date

Oct 9, 2013Estimated

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

Use of vasopressor to maintain Mean Arterial Pressure on Cardio Pulmonary Bypass can lead to decreased cerebral flow and oxygenation in individual patients and this can be detected by means of cerebral oxymetry.

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

54Actual

Label	Type	Description	Intervention Names
Cerebral oximetry

Measure	Description	Time Frame
Cerebral oxymetry values		March 2013

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient age under 80.
Patients should undergo elective coronary artery bypass grafting surgery (ACB) or heart valve surgery (AVR or MVR).
The patient must be admitted at least 18 years of years.

Exclusion Criteria:

Damage to the frontal lobes corresponding to the area where SCO2 monitored.
Patients in pharmacological studies.
Patients with known intracranial vascular anomalies or cerebral aneurysms.
Patients with known neurological disease.
Patients with known undergone cerebral insult, TIA or carotid stenosis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

We want to include 50 patients, both women and men, undergo elective coronary bypass surgery or valve surgeon in CPB with moderate hypothermia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ove A. Hagen, MD	Oslo Ùniversity Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo	Oslo	0424	Norway

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D001024	Aortic Valve Stenosis
D001022	Aortic Valve Insufficiency

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided