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

Mount Sinai Health System

Status and phase: Terminated; Phase 3

Conditions: Post-Operative Delirium; Postoperative Cognitive Dysfunction

Treatments: Procedure: SctO2 < 60 %.

Study type: Interventional

Funder types: Other

Identifiers

NCT00991328

GCO # 07-0332

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Cerebral Desaturation, i.e; SctO2 < 60 % for 5 minutes

Active Comparator group

Description:

Once the cerebral desaturation is established, the study personnel will attempt to optimize the level of oxygen within the brain of the study patients.

Treatment:

Procedure: SctO2 < 60 %.

Patients with SctO2 less than 60 %.

No Intervention group

Description:

The study patients will not get any intervention in this arm if the Sct02 falls below 60%