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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01940874
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : October 9, 2013
Information provided by (Responsible Party):
Oslo University Hospital

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.

Condition or disease
Coronary Artery Disease. Aortic Valve Stenosis. Aortic Valve Regurgitation.

Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Oxymetry at Elective Coronary and Valve Surgery: An Observational Study Using Norepinephrine to Maintain Arterial Blood Pressure on Cardio Pulmonary Bypass.
Study Start Date : February 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Cerebral oximetry

Primary Outcome Measures :
  1. Cerebral oxymetry values [ Time Frame: March 2013 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01940874

Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Ove A. Hagen, MD Oslo Ùniversity Hospital

Responsible Party: Oslo University Hospital Identifier: NCT01940874     History of Changes
Other Study ID Numbers: 2010/823
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013

Keywords provided by Oslo University Hospital:
Cerebral Oximetry.
Aortic valve stenosis.
Aortic valve regurgitation.
Coronary artery disease.

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction