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Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01149148
Enrollment
25
Registered
2010-06-23
Start date
2009-11-30
Completion date
2011-09-30
Last updated
2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cognitive Dysfunction

Keywords

Aortic Surgeries, Deep Hypothermic Circulatory Arrest

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.

Interventions

DEVICEINVOS 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%

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mini Mental State Examination (MMSE)BaselineThe 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.

Participant flow

Recruitment details

Recruitment period: 11-2009 to 9-2011

Participants by arm

ArmCount
Intervention INVOS Cerebral Oximetry Monitoring
\> 20% drop rSO2 from baseline or declines in rSO2 \< 50%
12
Standard of Care
Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
13
Total25

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath10
Overall StudyLost to Follow-up12

Baseline characteristics

CharacteristicTotalIntervention INVOS Cerebral Oximetry MonitoringStandard of Care
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
9 Participants2 Participants7 Participants
Age, Categorical
Between 18 and 65 years
16 Participants10 Participants6 Participants
Age, Continuous61.44 years
STANDARD_DEVIATION 10.3846
60.5 years
STANDARD_DEVIATION 9.414689
62.30769 years
STANDARD_DEVIATION 11.52088
Sex: Female, Male
Female
10 Participants5 Participants5 Participants
Sex: Female, Male
Male
15 Participants7 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 120 / 13
serious
Total, serious adverse events
1 / 120 / 13

Outcome results

Primary

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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Intervention INVOS Cerebral Oximetry MonitoringMini Mental State Examination (MMSE)27 scores on a scaleStandard Deviation 1.651
Standard of CareMini Mental State Examination (MMSE)26.769 scores on a scaleStandard Deviation 2.048
Comparison: The goal was to determine whether cerebral oximetry monitoring during surgery affected cognitive outcomes. Cerebral Oximetry Monitoring unblinded (intervention), and Cerebral Oxymetry Monitoring blinded (control) were given Mini Mental State Exam prior to surgery and three months after surgery. The differences between baseline and 3 month were calculated and compared between the intervention and control groups using t-test.p-value: 0.67895% CI: [-1.36, 2.02]t-test, 2 sided
Primary

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.

Time frame: 3 Months

Population: Not all participants completed 3 month follow up neurocognitive testing.

ArmMeasureValue (MEAN)Dispersion
Intervention INVOS Cerebral Oximetry MonitoringMini Mental State Examination (MMSE)27.667 Scores on a scaleStandard Deviation 2.121
Standard of CareMini Mental State Examination (MMSE)27 Scores on a scaleStandard Deviation 2.236

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026