Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients

• ClinicalTrials.gov Identifier: NCT01149148
• Recruitment Status: Completed
• First Posted: June 23, 2010
• Results First Posted: August 16, 2012
• Last Update Posted: April 28, 2015
• Sponsor: University of Michigan
• Information provided by (Responsible Party): Wei C Lau, MD, FAHA, University of Michigan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Cognitive Dysfunction	Device: INVOS Somanetics Cerebral Oximeter	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Effect of Regional Cerebral Oxygen Saturation Monitoring On Neurological Outcome In Patients Undergoing Aortic Arch Surgery
• Study Start Date: November 2009
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: September 2011

Arms and Interventions

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; Check head and cannula position; Increase mean arterial pressure; Increase pump flow; Increase systemic oxygenation; Increase PaCO2 > 45; Increase anesthetic depth by increasing volatile anesthetic or by administering propofol boluses; Consider PRBC transfusion for Hct < 21%
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; INVOS Cerebral Oximetry blinded monitoring with no deviation in surgical procedures or standard of care in anesthesia.

Outcome Measures

Primary Outcome Measures :

1. 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.

2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Wei C Lau, MD, FAHA, M.D., University of Michigan
• ClinicalTrials.gov Identifier: NCT01149148
• Other Study ID Numbers: UmichiganHS
• First Posted: June 23, 2010
• Results First Posted: August 16, 2012
• Last Update Posted: April 28, 2015
• Last Verified: August 2012

Keywords provided by Wei C Lau, MD, FAHA, University of Michigan:

Aortic Surgeries; Deep Hypothermic Circulatory Arrest

Additional relevant MeSH terms:

Postoperative Cognitive Complications; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes