Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients

NCT ID: NCT01149148

Last Updated: 2015-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-09-30

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.

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.

Conditions

Postoperative Cognitive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Intervention INVOS Cerebral Oximetry Monitoring

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

Group Type: ACTIVE_COMPARATOR

INVOS Somanetics Cerebral Oximeter

Intervention Type: 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%

Standard of Care

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

Group Type: ACTIVE_COMPARATOR

INVOS Somanetics Cerebral Oximeter

Intervention Type: DEVICE

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

Interventions

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%

Intervention Type: DEVICE

INVOS Somanetics Cerebral Oximeter

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Wei C Lau, MD, FAHA

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

UmichiganHS

Identifier Type: -

Identifier Source: org_study_id