Trial Outcomes & Findings for Cerebral Oximetry and Neurocognitive Functions in Cardiosurgical Patients (NCT NCT00917124)

NCT ID: NCT00917124

Last Updated: 2015-07-08

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 200 participants
• Primary outcome timeframe: preoperative, 7 days postoperative
• Results posted on: 2015-07-08

Participant Flow

Assessed for eligibility (n=287) Excluded (n=87) * Not meeting inclusion criteria (n=79) * Declined to participate (n=8)

Participant milestones

Measure	CONTROL The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.	INVOS 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.
Overall Study STARTED	100	100
Overall Study COMPLETED	96	94
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Measure	CONTROL The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.	INVOS 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.
Overall Study Protocol Violation	4	6

Baseline Characteristics

Cerebral Oximetry and Neurocognitive Functions in Cardiosurgical Patients

Baseline characteristics by cohort

Measure	CONTROL n=96 Participants The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.	INVOS n=94 Participants 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 n=190 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	48 Participants n=5 Participants	64 Participants n=7 Participants	112 Participants n=5 Participants
Age, Categorical >=65 years	48 Participants n=5 Participants	30 Participants n=7 Participants	78 Participants n=5 Participants
Age, Continuous	63.4 years STANDARD_DEVIATION 8.8 • n=5 Participants	61.9 years STANDARD_DEVIATION 7.1 • n=7 Participants	62.4 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	19 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants	75 Participants n=7 Participants	148 Participants n=5 Participants
Region of Enrollment Croatia	96 participants n=5 Participants	94 participants n=7 Participants	190 participants n=5 Participants
EuroSCORE	2.4 % - predicted mortality STANDARD_DEVIATION 1.7 • n=5 Participants	2.2 % - predicted mortality STANDARD_DEVIATION 1.7 • n=7 Participants	2.3 % - predicted mortality STANDARD_DEVIATION 1.7 • n=5 Participants
Ejection fraction	56 % STANDARD_DEVIATION 9.9 • n=5 Participants	56 % STANDARD_DEVIATION 9.7 • n=7 Participants	56 % STANDARD_DEVIATION 9.8 • n=5 Participants
Years of education	11.2 years STANDARD_DEVIATION 3.2 • n=5 Participants	11.3 years STANDARD_DEVIATION 3.4 • n=7 Participants	11.2 years STANDARD_DEVIATION 3.3 • n=5 Participants
Comorbidity - diabetes Diabetes	33 participants n=5 Participants	28 participants n=7 Participants	61 participants n=5 Participants
Comorbidity - diabetes Without diabetes	63 participants n=5 Participants	66 participants n=7 Participants	129 participants n=5 Participants
Comorbidity - hypertension Hypertension	85 participants n=5 Participants	79 participants n=7 Participants	164 participants n=5 Participants
Comorbidity - hypertension Without hypertension	11 participants n=5 Participants	15 participants n=7 Participants	26 participants n=5 Participants
Comorbidity - Myocardial infarction within 1 month before operation With preoperative myocardial infarction	12 participants n=5 Participants	8 participants n=7 Participants	20 participants n=5 Participants
Comorbidity - Myocardial infarction within 1 month before operation Without preoperative myocardial infarction	84 participants n=5 Participants	86 participants n=7 Participants	170 participants n=5 Participants
Comorbidity - Atrial fibrillation before operation Atrial fibrillation	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Comorbidity - Atrial fibrillation before operation Without atrial fibrillation	91 participants n=5 Participants	90 participants n=7 Participants	181 participants n=5 Participants
Bypass time	89 minutes STANDARD_DEVIATION 32 • n=5 Participants	91 minutes STANDARD_DEVIATION 31 • n=7 Participants	90 minutes STANDARD_DEVIATION 31 • n=5 Participants
Aortic cross-clamp time	62 minutes STANDARD_DEVIATION 26 • n=5 Participants	63 minutes STANDARD_DEVIATION 23 • n=7 Participants	63 minutes STANDARD_DEVIATION 25 • n=5 Participants

PRIMARY outcome

Timeframe: preoperative, 7 days postoperative

Population: 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

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

Outcome measures

Measure	CONTROL n=93 Participants The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.	INVOS n=88 Participants 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.
Difference in Incidence of Cognitive Impairment Between Groups. Change Between Preoperative and Postoperative Cognitive Function Was Assessed by Performing Standardized Neurocognitive Tests.	48 participants	25 participants

SECONDARY outcome

Timeframe: 7 postoperative days

Outcome measures

Measure	CONTROL n=96 Participants The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.	INVOS n=94 Participants 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.
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 Stroke, coma, stupor	1 participants	4 participants
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 Delirium	13 participants	8 participants
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 Prolonged mechanical ventilation	2 participants	1 participants
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 Myocardial infarction	7 participants	7 participants
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 Hemodialysis	1 participants	0 participants
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 Infection (any type)	18 participants	17 participants
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 Revision for bleeding	1 participants	0 participants
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 Atrial fibrillation	26 participants	21 participants
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 Hospital stay > 7 days	43 participants	44 participants

Adverse Events

INVOS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CONTROL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zeljko Colak

University Hospital Center Zagreb

Phone: 00385915624189

Email: zcolak2000@yahoo.com

Results disclosure agreements

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