CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
INVOSdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00917124
NCT00917124N/ACompleted

Influence of Intraoperative Monitoring of Cerebral Oximetry on Neurocognitive Function After Coronary Artery Bypass Surgery: Randomized, Prospective Study

University of Zagreb·interventional·Posted Jun 10, 2009·Updated Jul 8, 2015

In Brief

A clinical study evaluating INVOS for Coronary Artery Disease and 2 related conditions. Completed, enrolled 200 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCroatia
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 10, 2009
Enrollment StartJun 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.1 years ago

Interventions

INVOSdevice

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.