Cerebral Oximetry and Neurocognitive Functions in Cardiosurgical Patients

NCT00917124 | Completed Results

• 1 other identifier: KAI-AKA01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

It is previously reported that the cerebral oxygen desaturation during cardiac surgery is associated with an increased incidence of cognitive impairment. The aim of this study is to determine whether intraoperative monitoring and predetermined interventions protocol to improve cerebral oxygenation during coronary artery bypass surgery provides benefits in neurocognitive functions.

Conditions

Coronary Artery Disease; Postoperative Cognitive Dysfunction; Neurological Impairment

Keywords

cerebral oximetry; NIRS; INVOS

Outcome Measures

Primary Outcomes (1)

• Difference in Incidence of Cognitive Impairment Between Groups. Change Between Preoperative and Postoperative Cognitive Function Was Assessed by Performing Standardized Neurocognitive Tests.

  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

  preoperative, 7 days postoperative

Secondary Outcomes (1)

• 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

  7 postoperative days

Study Arms (2)

INVOS

ACTIVE COMPARATOR

INVOS : Cerebral oxygenation (rSO2) monitoring with INVOS. 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.

Device: INVOS

CONTROL

NO INTERVENTION

The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.

Interventions

INVOS DEVICE

Monitoring cerebral oxygenation (rSO2) with INVOS. When rSO2 decline occur it can be responded with simple interventions to prevent a brain injury including: repositioning of the head or perfusion cannulae to avoid mechanical obstruction of cerebral blood flow, increasing arterial carbon dioxide tension within normal referent values, increasing oxygen inspiration concentration to maintain adequate tissue oxygen saturation, increasing arterial blood pressure, pump flow rate and cardiac index, temperature decreasing and increasing of anesthetic depth to reduce cerebral oxygen consumption and blood transfusion if hematocrit decreases below 22%. None of the interventions are outside the range of good clinical practice.

Also known as: INVOS (in vivo optical spectroscopy), NIRS (near infrared spectroscopy)

INVOS

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with coronary artery disease undergoing coronary artery bypass grafting (CABG) with cardiopulmonary bypass

You may not qualify if:

• Who refuse to participate
• Previous stroke
• Preexisting psychiatric disease
• Significant carotid stenosis
• Ejection fraction below 25%
• Reoperations
• Emergent surgery
• Dialysis

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

University Hospital Center Zagreb

Zagreb, 10000, Croatia

Location

Related Publications (1)

• Colak Z, Borojevic M, Bogovic A, Ivancan V, Biocina B, Majeric-Kogler V. Influence of intraoperative cerebral oximetry monitoring on neurocognitive function after coronary artery bypass surgery: a randomized, prospective study. Eur J Cardiothorac Surg. 2015 Mar;47(3):447-54. doi: 10.1093/ejcts/ezu193. Epub 2014 May 7.

  PMID: 24810757 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Postoperative Cognitive Complications; Neurologic Manifestations

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

* 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

Results Point of Contact

• Title: Zeljko Colak
• Organization: University Hospital Center Zagreb

zcolak2000@yahoo.com

00385915624189

Study Officials

• Zeljko Colak, MD

  Clinical Hospital Centre Zagreb

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Influence of Intraoperative Monitoring of Cerebral Oximetry on Neurocognitive Function After Coronary Artery Bypass Surgery: Randomized, Prospective Study

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 10, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 8, 2015
• Results First Posted: August 7, 2013

Record last verified: 2015-06

Locations

CR (1)