Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients

April 27, 2015 updated by: Wei C Lau, MD, FAHA, University of Michigan

Effect of Regional Cerebral Oxygen Saturation Monitoring On Neurological Outcome In Patients Undergoing Aortic Arch Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Permanent or transient neurologic dysfunction is a frequent complication in patients undergoing aortic arch surgery.

Two basic methods of brain protection are currently used concomitantly with these complex surgical procedures: deep hypothermic circulatory arrest (DHCA) with or without retrograde cerebral perfusion (RCP)and selective antegrade hypothermic cerebral perfusion. Hypothermic circulatory arrest provides an optimal bloodless operative field, but the incidence of neurological dysfunction increases when the duration of DHCA exceeds 45-50 minutes. Antegrade cerebral perfusion is accomplished by means of direct differential cannulation of the common carotid and right subclavian arteries. Because this technique of brain protection requires a separate perfusion circuit, vigilant monitoring of perfusion pressure and flow rate is of utmost importance. Multiple studies have demonstrated that antegrade selective cerebral perfusion is a well established technique used for cerebral protection during aortic surgery requiring longer periods of DHCA with favorable results in hospital mortality and neurologic outcome. The permanent neurological dysfunction was noted to be 3.8% and the transient neurologic dysfunction to be 7.1% for patients that received antegrade selective cerebral perfusion.

Similarly, neurocognitive studies of DHCA with antegrade cerebral perfusion for patients undergoing aortic arch operations demonstrated 9 % transient neurocognitive impairment for 2 days postoperatively that lasted up to 3 weeks thereafter. Consistent with current surgical practice, the University of Michigan uses antegrade selective cerebral perfusion for all patients undergoing aortic arch surgery requiring DHCA with or without RCP.

A number of monitoring modalities have been used for detecting cerebral malperfusion during aortic surgery or carotid surgery, including transcranial Doppler ultrasound and near infrared spectroscopy (NIRS).

The impact of these monitoring modalities on clinical (neurologic) outcome has not been clearly established. Currently, NIRS has gained considerable attention and acceptance as a non-invasive monitor of cerebral oxygenation. One study showed that a sustained drop in the regional oxygen saturation (rSO2) below 55% for over 5 minutes using cerebral oximetry is closely related to the occurrence of neurological events following aortic surgery. Another study strongly supported that rSO2 should not drop > 20% from baseline to prevent neurologic compromise. In a cohort of elective coronary artery bypass graph (CABG) patients, intervention for cerebral desaturations did show significantly less major organ morbidity or mortality (death, ventilation > 48 h, stroke, myocardial infarction, return for re-exploration. Whether NIRS can be used as a monitor to provide rapid detection and prevention of cerebral ischemia by early intervention that may improve neurological outcome in patients undergoing aortic surgery requiring DHCA with or without RCP is currently unknown.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult male and female patients 18-80 years of age scheduled for aortic surgery requiring DHCA and intention to use antegrade selective cerebral perfusion with or without RCP

Exclusion Criteria:

  • Adult male and female patients 18-80 years of age undergoing aortic surgery NOT scheduled for DHCA
  • Patients with ejection fraction < 15%
  • Pregnancy
  • Prisoners
  • Patients mentally impaired (Screening Criteria i.e. MMSE score ≤ 23) History of stroke

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intervention INVOS Cerebral Oximetry Monitoring
Intervention will be initiated if rSO2 drops > 20% from baseline or rSO2 declines below 50%.
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.
ACTIVE_COMPARATOR: Standard of Care
Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini Mental State Examination (MMSE)
Time Frame: Baseline

The Mini-Mental State Examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment at a specific time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. MMSE = Mini Mental State Exam - measures general orientation and mental status.

Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems.
Baseline
Mini Mental State Examination (MMSE)
Time Frame: 3 Months

The Mini-Mental State Examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment at a specific time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. MMSE = Mini Mental State Exam - measures general orientation and mental status.

Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems.
3 Months

Collaborators and Investigators

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

Sponsor

University of Michigan

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

November 1, 2009

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

June 21, 2010

First Submitted That Met QC Criteria

June 22, 2010

First Posted (ESTIMATE)

June 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UmichiganHS

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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