Trial Outcomes & Findings for Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients (NCT NCT01149148)

NCT ID: NCT01149148

Last Updated: 2015-04-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 25 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2015-04-28

Participant Flow

Recruitment period: 11-2009 to 9-2011

Participant milestones

Measure	Intervention INVOS Cerebral Oximetry Monitoring \> 20% drop rSO2 from baseline or declines in rSO2 \< 50%	Standard of Care Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
Overall Study STARTED	12	13
Overall Study COMPLETED	10	11
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Intervention INVOS Cerebral Oximetry Monitoring \> 20% drop rSO2 from baseline or declines in rSO2 \< 50%	Standard of Care Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
Overall Study Lost to Follow-up	1	2
Overall Study Death	1	0

Baseline Characteristics

Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients

Baseline characteristics by cohort

Measure	Intervention INVOS Cerebral Oximetry Monitoring n=12 Participants \> 20% drop rSO2 from baseline or declines in rSO2 \< 50%	Standard of Care n=13 Participants Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Age, Continuous	60.5 years STANDARD_DEVIATION 9.414689 • n=5 Participants	62.30769 years STANDARD_DEVIATION 11.52088 • n=7 Participants	61.44 years STANDARD_DEVIATION 10.3846 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention INVOS Cerebral Oximetry Monitoring n=12 Participants \> 20% drop rSO2 from baseline or declines in rSO2 \< 50%	Standard of Care n=13 Participants Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
Mini Mental State Examination (MMSE)	27 scores on a scale Standard Deviation 1.651	26.769 scores on a scale Standard Deviation 2.048

PRIMARY outcome

Timeframe: 3 Months

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

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.

Outcome measures

Measure	Intervention INVOS Cerebral Oximetry Monitoring n=9 Participants \> 20% drop rSO2 from baseline or declines in rSO2 \< 50%	Standard of Care n=9 Participants Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
Mini Mental State Examination (MMSE)	27.667 Scores on a scale Standard Deviation 2.121	27 Scores on a scale Standard Deviation 2.236

Adverse Events

Intervention INVOS Cerebral Oximetry Monitoring

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention INVOS Cerebral Oximetry Monitoring n=12 participants at risk \> 20% drop rSO2 from baseline or declines in rSO2 \< 50%	Standard of Care n=13 participants at risk Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
Cardiac disorders Death	8.3% 1/12	0.00% 0/13

Other adverse events

Adverse event data not reported

Additional Information

Dr. Wei C. Lau

UmichiganHS

Phone: 734 9369479

Email: weiclau@med.umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place