CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 25 enrolled
Drug / intervention
INVOS Somanetics Cerebral Oximeter +1 moredevice
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/NCT01149148
NCT01149148Phase 3Completed

Effect of Regional Cerebral Oxygen Saturation Monitoring On Neurological Outcome In Patients Undergoing Aortic Arch Surgery

University of Michigan·interventional·Posted Jun 23, 2010·Updated Apr 28, 2015

In Brief

A Phase 3 clinical trial evaluating INVOS Somanetics Cerebral Oximeter for Postoperative Cognitive Dysfunction. Completed, enrolled 25 participants.

Detailed Summary

The investigators hypothesize that early intervention to optimize regional cerebral oxygenation detected by cerebral oximetry monitoring during deep hypothermic circulatory arrest (DHCA) for patients undergoing aortic surgery will decrease the incidence of transient and permanent neurological dysfunction and improve neurocognitive impairment.

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 23, 2010
Enrollment StartNov 1, 2009
Primary CompletionMay 1, 2010
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.0 years ago

Interventions

INVOS Somanetics Cerebral Oximeterdevice

Sequence of Interventions To Increase Cerebral Oxygen Saturation 1. Check head and cannula position 2. Increase mean arterial pressure 3. Increase pump flow 4. Increase systemic oxygenation 5. Increase PaCO2 \> 45 6. Increase anesthetic depth by increasing volatile anesthetic or by administering propofol boluses 7. Consider PRBC transfusion for Hct \< 21%

INVOS Somanetics Cerebral Oximeterdevice

INVOS Cerebral Oximetry blinded monitoring with no deviation in surgical procedures or standard of care in anesthesia.