Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients

NCT01149148 | Completed Phase 3 Results

• 1 other identifier: UmichiganHS
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Aortic Surgeries; Deep Hypothermic Circulatory Arrest

Outcome Measures

Primary Outcomes (2)

• Mini Mental State Examination (MMSE)

  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)

  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

Study Arms (2)

Intervention INVOS Cerebral Oximetry Monitoring

ACTIVE COMPARATOR

Intervention will be initiated if rSO2 drops \> 20% from baseline or rSO2 declines below 50%.

Device: INVOS Somanetics Cerebral Oximeter

Standard of Care

ACTIVE COMPARATOR

Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.

Device: INVOS Somanetics Cerebral Oximeter

Interventions

INVOS Somanetics Cerebral Oximeter DEVICE

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%

Intervention INVOS Cerebral Oximetry Monitoring

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

The study was discontinued after 25 subjects completed.

Results Point of Contact

• Title: Dr. Wei C. Lau
• Organization: UmichiganHS

weiclau@med.umich.edu

734 9369479

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 23, 2010
• Study Start: November 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: September 1, 2011
• Last Updated: April 28, 2015
• Results First Posted: August 16, 2012

Record last verified: 2012-08