Correlating Brain Tissue Oxygen and Regional Cerebral Oximetry

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: IVOS cerebral oximeter; Device: Licox cerebral oxygenation monitor; Other: Cerebral oxygenation

• Registration Number: NCT03128957
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-25
• Study Start: 2017-06-29
• Primary Completion: 2021-06-22
• Study Completion: 2021-06-22
• Results First Submitted: 2022-06-25
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-10
• Last Update Submitted: 2022-08-10
• Results First Posted: 2022-09-01
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Patients who are scheduled for elective removal of secondary cerebral metastases under general anesthesia.

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Exclusion Criteria

• Patients will be excluded if they refuse to give consent, have evidence of elevated intracranial pressure on preoperative CT scan, have coagulopathy, are taking therapeutic agents known to increase bleeding risk, have a history of cardiovascular disease, cerebrovascular disease, suffer from respiratory failure, or are not fluent English speakers.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Varying cerebral oxygenation with varying ventilation	IVOS cerebral oximeter	Compare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen
Varying cerebral oxygenation with varying ventilation	Licox cerebral oxygenation monitor	Compare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen
Varying cerebral oxygenation with varying ventilation	Cerebral oxygenation	Compare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen

Primary Outcome Measures

Name	Time	Method
Correlation Between Regional Cerebral Oximetry (RSO2) and Cerebral Oxygen Tissue Tension (PbrO2).	Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes	Correlation - correlation coefficient between cerebral oxygenation measured by Licox and INVOS oxygen measurement systems subsequent upon changes in ventilation strategy; Spearman correlation describes the strength of the monotonic relationship between two measures and is bounded between -1 and 1. Negative values indicate an inverse relationship while positive values mean that the variables move in tandem.; \[Example of correlation coefficient in CT.gov: NCT02318667\]

Secondary Outcome Measures

Name	Time	Method
Changes in PbrO2 Resultant Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction	Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes	PbrO2 - measured in millimeters of mercury(mmHg); Steady State PbrO2 Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction after Equilibration for each Set Point
Changes in rSO2 Resultant Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction	Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes	rSO2 - %saturation; Steady State rSO2 Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction after Equilibration for each Set Point

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States