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Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients

NCT01149148 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-04-28

Study results available
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Summary

The investigators hypothesize that early intervention to optimize regional cerebral oxygenation detected by cerebral oximetry monitoring during deep hypothermic circulatory arrest (DHCA) for patients undergoing aortic surgery will decrease the incidence of transient and permanent neurological dysfunction and improve neurocognitive impairment.

Conditions

  • Postoperative Cognitive Dysfunction

Interventions

DEVICE

INVOS Somanetics Cerebral Oximeter

Sequence of Interventions To Increase Cerebral Oxygen Saturation 1. Check head and cannula position 2. Increase mean arterial pressure 3. Increase pump flow 4. Increase systemic oxygenation 5. Increase PaCO2 \> 45 6. Increase anesthetic depth by increasing volatile anesthetic or by administering propofol boluses 7. Consider PRBC transfusion for Hct \< 21%

DEVICE

INVOS Somanetics Cerebral Oximeter

INVOS Cerebral Oximetry blinded monitoring with no deviation in surgical procedures or standard of care in anesthesia.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-05-31
Completion
2011-09-30

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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 NCT01149148 on ClinicalTrials.gov