Role of Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery

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: NCT00991328
Recruitment Status : Terminated (low enrollment)
First Posted : October 8, 2009
Last Update Posted : September 16, 2016
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:
The purpose of this study is to determine whether brain oxygenation measured by cerebral oximeter has an impact on neurocognitive dysfunction.

Condition or disease Intervention/treatment Phase
Post-Operative Delirium Postoperative Cognitive Dysfunction Procedure: SctO2 < 60 %. Phase 3

Detailed Description:

Both postoperative delirium (PD) and postoperative cognitive dysfunction (POCD) are well known complications seen in elderly patients after cardiac surgery. The etiologies of PD and POCD are unknown, but cerebral ischemia remains a prime candidate. Attempts to correlate reduced levels of systemic oxygenation (i.e. SpO2) with the development of PD/POCD have been to date disappointing.

We believe that cerebral oximetry, a noninvasive technology that continuously monitors cerebral tissue oxygen saturation (SctO2), will enable us to answer the question of whether or not a correlation exists.

The availability of an absolute cerebral oximeter (FORE-SIGHT), with its ability to establish and manipulate threshold values for SctO2, provides us the opportunity to assess the relationship between cerebral oxygenation and the development of neurocognitive complications.

We propose a randomized, masked trial of 120 patients, adequately powered to assess the following:

  • Is there an association between deficits in cerebral oxygenation and the occurrence of PD at some time in the 1st 5 days after the operation?
  • Is there an association between deficits in cerebral oxygenation and changes in POCD scores shortly (5 days) after the operation and/or 4-6 weeks later? We hypothesize that individually tailored patient management guided with intraoperative and postoperative absolute cerebral oximetry monitoring using a tailored protocol designed to maintain SctO2 values above a specific threshold will result in improved neurocognitive outcomes in geriatric patients undergoing cardiac surgery.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Tailored Patient Management Guided With Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery.
Study Start Date : September 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Active Comparator: Cerebral Desaturation, i.e; SctO2 < 60 % for 5 minutes
Once the cerebral desaturation is established, the study personnel will attempt to optimize the level of oxygen within the brain of the study patients.
Procedure: SctO2 < 60 %.
The following intervention protocol will be applied when SctO2 level falls below 60 %. First, the patients head position will be checked for suitable position and the face will be observed for plethora. Then the efforts will be made to maintain PaCO2 between 40-50 mmHg and MAP of 60 - 80 mm Hg. Cardiac index will be maintained between 2.0 - 2.5 L/min/m2. The hematocrit should be more than 20 %. The red blood cells or hemoconcentration will be used for this purpose.

No Intervention: Patients with SctO2 less than 60 %.
The study patients will not get any intervention in this arm if the Sct02 falls below 60%

Primary Outcome Measures :
  1. The association of Postoperative Delirium (PD) and Postoperative Cognitive Dysfunction (POCD) with changes in cerebral tissue oxygen saturation (SctO2). [ Time Frame: First 5 days after the cardiac surgery. ]

Secondary Outcome Measures :
  1. Postoperative Morbidity and Mortality [ Time Frame: 3 months postoperatively ]

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 65 and older
  • Elective cardiac or thoracic aortic surgery
  • Capable and willing to consent
  • Participants literate in English

Exclusion Criteria:

  • Emergency Surgery
  • Major Neurological Disease
  • Gross Cognitive Dysfunction
  • Patients not expected to be able to complete the 1 week and 3 months post-operative visit.

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): NCT00991328

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Principal Investigator: Gregory Fischer, M.D. Icahn School of Medicine at Mount Sinai


Responsible Party: Icahn School of Medicine at Mount Sinai Identifier: NCT00991328     History of Changes
Other Study ID Numbers: GCO # 07-0332
First Posted: October 8, 2009    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016

Keywords provided by Icahn School of Medicine at Mount Sinai:
Post-op Delirium (PD)
Post-op Cognitive Dysfunction (POCD)

Additional relevant MeSH terms:
Cognitive Dysfunction
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Cognition Disorders