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

September 14, 2016 updated by: Icahn School of Medicine at Mount Sinai

Tailored Patient Management Guided With Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery.

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

15

Phase

  • Phase 3

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

  • United States
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
First 5 days after the cardiac surgery.

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative Morbidity and Mortality
Time Frame: 3 months postoperatively
3 months postoperatively

Collaborators and Investigators

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

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Gregory Fischer, M.D., Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 2, 2009

First Submitted That Met QC Criteria

October 7, 2009

First Posted (Estimate)

October 8, 2009

Study Record Updates

Last Update Posted (Estimate)

September 16, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO # 07-0332

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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