CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
IVOS cerebral oximeter +2 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/NCT03128957
NCT03128957N/ACompleted

Correlating Brain Tissue Oxygen Tension (PbrO2) and Regional Cerebral Oximetry (rSO2) in Normal Human Brain Under the Conditions of Changing Ventilation Strategy

University of Michigan·interventional·Posted Apr 25, 2017·Updated Sep 1, 2022

In Brief

A clinical study evaluating IVOS cerebral oximeter, Licox cerebral oxygenation monitor, and 1 other intervention for Stroke. Completed, enrolled 12 participants across 1 site.

Detailed Summary

Controversy surrounds the use of regional cerebral oximetry (rSO2) as a measure of true cerebral oxygenation because of extracranial signal contamination and unmeasured confounding of cerebral a:v ratio. The measurement of brain tissue oxygen (PbrO2) has been used in routine neurosurgery and has been shown to reliably demonstrate cerebral hypoxia following severe head injury. It is the most direct measure of cerebral oxygenation. Here, we test the hypothesis that there is a correlation between PbrO2 and rSO2 under conditions of varying inspired oxygen fraction and the varying partial pressure of carbon dioxide in arterial blood in uninjured, normal human brain. Patients who are scheduled for elective removal of secondary cerebral metastases under general anesthesia will be recruited following written informed consent obtained by a study team member during their preoperative evaluation. BIS and rSO2 optodes will be applied, before induction of anesthesia, by a single researcher on both sides of the patient's forehead, as recommended by the manufacturer. General anesthesia will be maintained by total intravenous anesthesia (TIVA) with a combination of propofol (80-150 mcg/kg/min) and remifentanil (0.05-0.1 mcg/kg/min) targeted to a Bispectral Index range 40-60 (BIS; Covidien, Boulder, CO). Following craniotomy, the LICOX probe will be placed under direct vision into an area of normal brain within the tumor excision canal by the attending neurosurgeon. During a pause in surgery FIO2 and minute ventilation will be sequentially adjusted to achieve the following pairs of ventilation set points: 1) FIO2 0.3 and paCO2 30mmHg, 2) FIO2 1.0 and paCO2 40mmHg. After ≥5 minutes at each set point FIO2, PaCO2, rSO2 and PbrO2 will be recorded as a "snap-shot". A sample size of 15 achieves an 80% power with a one-sided type I error of 5% to detect a positive correlation of 0.6 (from the null hypothesis of no correlation) between changes in PbrO2 and changes in rSO2 subsequent on alterations made in ventilation strategy. Correlation will be measured using Pearson's Correlation. P values \< 0.05 will be considered statistically significant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 25, 2017
Enrollment StartJun 29, 2017
Primary CompletionJun 22, 2021
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 9.2 years ago

Interventions

IVOS cerebral oximeterdevice

Measuring percutaneous cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.

Licox cerebral oxygenation monitordevice

Measuring tissue cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction.

Cerebral oxygenationother

Measuring cerebral oxygenation with varying ventilation strategy