Cerebral Oxymetry at Elective Coronary and Valve Surgery. (Co-HLM)

October 8, 2013 updated by: Oslo University Hospital

Cerebral Oxymetry at Elective Coronary and Valve Surgery: An Observational Study Using Norepinephrine to Maintain Arterial Blood Pressure on Cardio Pulmonary Bypass.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cerebral oximetry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cerebral oxymetry values
Time Frame: March 2013
March 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Ove A. Hagen, MD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (Estimate)

September 12, 2013

Study Record Updates

Last Update Posted (Estimate)

October 9, 2013

Last Update Submitted That Met QC Criteria

October 8, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/823

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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