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

NCT00991328 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-09-16

No results posted yet for this study

Summary

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

Conditions

  • Post-Operative Delirium
  • Postoperative Cognitive Dysfunction

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Gregory Fischer, M.D. · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00991328 on ClinicalTrials.gov