N/A
N=200
Cerebral Oximetry and Neurocognitive Functions in Cardiosurgical Patients
Coronary Artery Disease · Postoperative Cognitive Dysfunction · Neurological Impairment
Bottom Line
View on ClinicalTrials.gov: NCT00917124 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Difference in Incidence of Cognitive Impairment Between Groups. Change Between Preoperative and Postoperative Cognitive Function Was Assessed by Performing Standardized Neurocognitive Tests. — 48; 25 participants — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- INVOS (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Zagreb
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Incidence of Cognitive Impairment Between Groups. Change Between Preoperative and Postoperative Cognitive Function Was Assessed by Performing Standardized Neurocognitive Tests. |
48; 25 | 0.002 sig |
| SECONDARY 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 |
1; 4; 13; 8; 2; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- All patients with coronary artery disease undergoing coronary artery bypass grafting (CABG) with cardiopulmonary bypass
Exclusion Criteria
- Who refuse to participate
- Previous stroke
- Preexisting psychiatric disease
- Significant carotid stenosis
- Ejection fraction below 25%
- Reoperations
- Emergent surgery
- Dialysis
Data sourced from ClinicalTrials.gov (NCT00917124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.