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Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients

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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:
Information provided by (Responsible Party):
Wei C Lau, MD, FAHA, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Condition Postoperative Cognitive Dysfunction
Intervention Device: INVOS Somanetics Cerebral Oximeter
Enrollment 25

Recruitment Details Recruitment period: 11-2009 to 9-2011
Pre-assignment Details  
Arm/Group Title Intervention INVOS Cerebral Oximetry Monitoring Standard of Care
Hide Arm/Group Description > 20% drop rSO2 from baseline or declines in rSO2 < 50% Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
Period Title: Overall Study
Started 12 13
Completed 10 11
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             1             2
Death             1             0
Arm/Group Title Intervention INVOS Cerebral Oximetry Monitoring Standard of Care Total
Hide Arm/Group Description > 20% drop rSO2 from baseline or declines in rSO2 < 50% Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care. Total of all reporting groups
Overall Number of Baseline Participants 12 13 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  83.3%
6
  46.2%
16
  64.0%
>=65 years
2
  16.7%
7
  53.8%
9
  36.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 13 participants 25 participants
60.5  (9.414689) 62.30769  (11.52088) 61.44  (10.3846)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
Female
5
  41.7%
5
  38.5%
10
  40.0%
Male
7
  58.3%
8
  61.5%
15
  60.0%
1.Primary Outcome
Title Mini Mental State Examination (MMSE)
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention INVOS Cerebral Oximetry Monitoring Standard of Care
Hide Arm/Group Description:
> 20% drop rSO2 from baseline or declines in rSO2 < 50%
Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: scores on a scale
27  (1.651) 26.769  (2.048)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention INVOS Cerebral Oximetry Monitoring, Standard of Care
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.678
Comments A prior threshold for statistical significance is p < 0.05
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3333
Confidence Interval (2-Sided) 95%
-1.36 to 2.02
Parameter Dispersion
Type: Standard Deviation
Value: 1.626
Estimation Comments The difference between baseline and three months is (baseline – 3 month). The difference in control and intervention is (intervention – control), which in this case is (unblinded – blinded).
2.Primary Outcome
Title Mini Mental State Examination (MMSE)
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not all participants completed 3 month follow up neurocognitive testing.
Arm/Group Title Intervention INVOS Cerebral Oximetry Monitoring Standard of Care
Hide Arm/Group Description:
At the start of surgery two sensor pads will be placed on the patients forehead and attached to the INVOS Monitoring System. If the rSO2 values decrease >20% from baseline or decline below 50 the anesthesiologist will initiate an intervention: Increase mean arterial pressure, check head and cannula position, increase pump flow, increase systemic oxygenation, increase PaCo2 >45, increase anesthetic depth by increaseing volatile anesthetic or administering propoful boluses, consider PRBC transfusion for Hct<21%.
Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
27.667  (2.121) 27  (2.236)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention INVOS Cerebral Oximetry Monitoring Standard of Care
Hide Arm/Group Description > 20% drop rSO2 from baseline or declines in rSO2 < 50% Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
All-Cause Mortality
Intervention INVOS Cerebral Oximetry Monitoring Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention INVOS Cerebral Oximetry Monitoring Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   1/12 (8.33%)   0/13 (0.00%) 
Cardiac disorders     
Death  [1]  1/12 (8.33%)  0/13 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Patient died during surgery as a result of aortic tear. Not related to study intervention.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention INVOS Cerebral Oximetry Monitoring Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/13 (0.00%) 
The study was discontinued after 25 subjects completed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Wei C. Lau
Organization: UmichiganHS
Phone: 734 9369479
Responsible Party: Wei C Lau, MD, FAHA, University of Michigan
ClinicalTrials.gov Identifier: NCT01149148     History of Changes
Other Study ID Numbers: UmichiganHS
First Submitted: June 21, 2010
First Posted: June 23, 2010
Results First Submitted: March 26, 2012
Results First Posted: August 16, 2012
Last Update Posted: April 28, 2015