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Trial record 61 of 667 for:    CARBON DIOXIDE AND arterial

Cerebral Oximetry and Neurocognitive Functions in Cardiosurgical Patients

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ClinicalTrials.gov Identifier: NCT00917124
Recruitment Status : Completed
First Posted : June 10, 2009
Results First Posted : August 7, 2013
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Zeljko Colak, University of Zagreb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Coronary Artery Disease
Postoperative Cognitive Dysfunction
Neurological Impairment
Intervention Device: INVOS
Enrollment 200
Recruitment Details

Assessed for eligibility (n=287) Excluded (n=87)

  • Not meeting inclusion criteria (n=79)
  • Declined to participate (n=8)
Pre-assignment Details  
Arm/Group Title CONTROL INVOS
Hide Arm/Group Description The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed. INVOS (In Vivo optical Spectroscopy): Monitoring cerebral oxygenation (rSO2) with INVOS device. When rSO2 decline occur (decrease of rSO2 for more than 20% from patient's baseline value) it can be responded with simple interventions to prevent a brain injury. These interventions include: repositioning of the head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
Period Title: Overall Study
Started 100 100
Completed 96 94
Not Completed 4 6
Reason Not Completed
Protocol Violation             4             6
Arm/Group Title CONTROL INVOS Total
Hide Arm/Group Description The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed. INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion. Total of all reporting groups
Overall Number of Baseline Participants 96 94 190
Hide Baseline Analysis Population Description
Only patients underwent coronary artery bypass grafting (CABG) with cardiopulmonary bypass were included in the study. Four participants in Control group and six participants in INVOS group were not analysed because they did not receive allocated surgical intervention (CABG), because intraoperative plan was changed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 94 participants 190 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
48
  50.0%
64
  68.1%
112
  58.9%
>=65 years
48
  50.0%
30
  31.9%
78
  41.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants 94 participants 190 participants
63.4  (8.8) 61.9  (7.1) 62.4  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 94 participants 190 participants
Female
23
  24.0%
19
  20.2%
42
  22.1%
Male
73
  76.0%
75
  79.8%
148
  77.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Croatia Number Analyzed 96 participants 94 participants 190 participants
96 94 190
EuroSCORE   [1] 
Mean (Standard Deviation)
Unit of measure:  % - predicted mortality
Number Analyzed 96 participants 94 participants 190 participants
2.4  (1.7) 2.2  (1.7) 2.3  (1.7)
[1]
Measure Description: EuroSCORE (European system for cardiac operative risk evaluation) is a method of calculating predicted operative mortality for patients undergoing cardiac surgery. The outcome (survival or death) was related to the preoperative risk factors. If a risk factor is present in a patient, the weights are added to give an approximate percent predicted mortality. Two online risk calculators are available: the simple additive EuroSCORE and the logistic EuroSCORE. We used the logistic version of EuroSCORE which provides more accurate predicted mortality according to the logistic regression equation.
Ejection fraction  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 96 participants 94 participants 190 participants
56  (9.9) 56  (9.7) 56  (9.8)
Years of education  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants 94 participants 190 participants
11.2  (3.2) 11.3  (3.4) 11.2  (3.3)
Comorbidity - diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 96 participants 94 participants 190 participants
Diabetes 33 28 61
Without diabetes 63 66 129
Comorbidity - hypertension  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 96 participants 94 participants 190 participants
Hypertension 85 79 164
Without hypertension 11 15 26
Comorbidity - Myocardial infarction within 1 month before operation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 96 participants 94 participants 190 participants
With preoperative myocardial infarction 12 8 20
Without preoperative myocardial infarction 84 86 170
Comorbidity - Atrial fibrillation before operation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 96 participants 94 participants 190 participants
Atrial fibrillation 5 4 9
Without atrial fibrillation 91 90 181
Bypass time  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 96 participants 94 participants 190 participants
89  (32) 91  (31) 90  (31)
Aortic cross-clamp time  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 96 participants 94 participants 190 participants
62  (26) 63  (23) 63  (25)
1.Primary Outcome
Title Difference in Incidence of Cognitive Impairment Between Groups. Change Between Preoperative and Postoperative Cognitive Function Was Assessed by Performing Standardized Neurocognitive Tests.
Hide Description

The Mini-Mental State Examination (MMSE) total score is calculated by summing the item scores across several aspects of cognition. The maximum possible total score is 30 points.

Color Trials Test (CTT) measures sustained visual attention, visual scanning and graphomotor skills. The examiner records the length of time (in seconds) required by the patient to rapidly draw a line connecting the circles numbered 1 through 25 in consecutive order.

Grooved-Pegboard test (GP test) is manipulative dexterity test that contains twenty-five holes with randomly positioned slots and pegs which have a key along one side. Pegs must be rotated to match the hole before they can be inserted. The examiner records the time in seconds.

Cognitive impairment was defined as a decline in postoperative performance in one or more tests: decrease of MMSE score three points or more from baseline and decrease of one standard deviation or more in performance on CTT 1 and GP tests

Time Frame preoperative, 7 days postoperative
Hide Outcome Measure Data
Hide Analysis Population Description

3 participants in Control group did not perform control cognitive test- transferred to another hospital.

6 participants in INVOS group did not perform control cognitive test - transferred to another hospital n=4, declined to participate n=2

Arm/Group Title CONTROL INVOS
Hide Arm/Group Description:
The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
Overall Number of Participants Analyzed 93 88
Measure Type: Number
Unit of Measure: participants
48 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CONTROL, INVOS
Comments

Hypothesis: intraoperative monitoring of cerebral oxigenation with INVOS system will improve cognitive outcome of patients undergoing CABG procedure.

Sample size was determined assuming 50% incidence of cognitive impairment after cardiac surgery and possibility of decreasing that incidence to 30% using cerebral oximetry. Based on 0.8 power to detect a significant difference (p=0.05), 90 patients were required for each study group.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
2.Secondary Outcome
Title Evidence of Coma, Stupor, Cerebral Insult, Delirium, Ventilation Longer Than 24 Hours, Myocardial Infarction, Atrial Fibrillation, Dialysis, Reoperation for Bleeding, Infection, Hospital Stay > 7 Days
Hide Description [Not Specified]
Time Frame 7 postoperative days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CONTROL INVOS
Hide Arm/Group Description:
The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
Overall Number of Participants Analyzed 96 94
Measure Type: Number
Unit of Measure: participants
Stroke, coma, stupor 1 4
Delirium 13 8
Prolonged mechanical ventilation 2 1
Myocardial infarction 7 7
Hemodialysis 1 0
Infection (any type) 18 17
Revision for bleeding 1 0
Atrial fibrillation 26 21
Hospital stay > 7 days 43 44
Time Frame seven postoperative days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title INVOS CONTROL
Hide Arm/Group Description INVOS : Monitoring cerebral oxygenation (rSO2) with INVOS. When rSO2 decline occur (decrease of rSO2 for more than 20% from patient's baseline value) it can be responded with simple interventions to prevent a brain injury. These interventions include: repositioning of the head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion. The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
All-Cause Mortality
INVOS CONTROL
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
INVOS CONTROL
Affected / at Risk (%) Affected / at Risk (%)
Total   0/94 (0.00%)   0/96 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
INVOS CONTROL
Affected / at Risk (%) Affected / at Risk (%)
Total   0/94 (0.00%)   0/96 (0.00%) 
  • number and selection of performed neurocognitive tests. MMSE test is not part of "Statement of consensus on assessment of neurobehavioral outcomes after cardiac surgery"
  • lack of blind monitoring of cerebral oximetry in control group
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Zeljko Colak
Organization: University Hospital Center Zagreb
Phone: 00385915624189
EMail: zcolak2000@yahoo.com
Layout table for additonal information
Responsible Party: Zeljko Colak, University of Zagreb
ClinicalTrials.gov Identifier: NCT00917124     History of Changes
Other Study ID Numbers: KAI-AKA01
First Submitted: June 9, 2009
First Posted: June 10, 2009
Results First Submitted: April 9, 2013
Results First Posted: August 7, 2013
Last Update Posted: July 8, 2015