Trial Outcomes & Findings for Correlating Brain Tissue Oxygen and Regional Cerebral Oximetry (NCT NCT03128957)

Last Updated: 2022-09-01

Results Overview

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. \[Example of correlation coefficient in CT.gov: NCT02318667\]

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes

Results posted on

2022-09-01

Participant Flow

A total of 12 subjects were consented, two were excluded for logistical reasons prior to any data collection.

Participant milestones

Participant milestones
Measure	Varying Cerebral Oxygenation With Varying Ventilation Compare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen IVOS cerebral oximeter: Measuring percutaneous cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction. Licox cerebral oxygenation monitor: Measuring tissue cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction. Cerebral oxygenation: Measuring cerebral oxygenation with varying ventilation strategy
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Correlating Brain Tissue Oxygen and Regional Cerebral Oximetry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Varying Cerebral Oxygenation With Varying Ventilation n=10 Participants Compare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen IVOS cerebral oximeter: Measuring percutaneous cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction. Licox cerebral oxygenation monitor: Measuring tissue cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction. Cerebral oxygenation: Measuring cerebral oxygenation with varying ventilation strategy
Age, Continuous	61.4 years STANDARD_DEVIATION 9.6 • n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	10 Participants n=93 Participants

PRIMARY outcome

Timeframe: Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes

Population: One subject's data was identified as an extreme value using the Tuckey Fences approach and was excluded from primary analysis.

Outcome measures

Outcome measures
Measure	Varying Cerebral Oxygenation With Varying Ventilation n=9 Participants Compare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen IVOS cerebral oximeter: Measuring percutaneous cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction. Licox cerebral oxygenation monitor: Measuring tissue cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction. Cerebral oxygenation: Measuring cerebral oxygenation with varying ventilation strategy
Correlation Between Regional Cerebral Oximetry (RSO2) and Cerebral Oxygen Tissue Tension (PbrO2).	.5 Spearman Correlation (rs) Coefficient

SECONDARY outcome

Timeframe: Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes

Population: One participant was identified as an extreme value using the Tuckey Fences approach and was excluded from final analysis.

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

Outcome measures

Outcome measures
Measure	Varying Cerebral Oxygenation With Varying Ventilation n=9 Participants Compare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen IVOS cerebral oximeter: Measuring percutaneous cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction. Licox cerebral oxygenation monitor: Measuring tissue cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction. Cerebral oxygenation: Measuring cerebral oxygenation with varying ventilation strategy
Changes in PbrO2 Resultant Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction Set point 1 (FiO2 0.3 and PaCO2 30 mmHg)	6.0 mmHg Interval 4.0 to 11.3
Changes in PbrO2 Resultant Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction Set point 2 (FiO2 1.0 and PaCO2 40 mmHg)	22.5 mmHg Interval 9.8 to 43.6

SECONDARY outcome

Timeframe: Time required for cerebral oxygenation to reach equilibrium following a change in ventilation - typically less than 20 minutes

Population: One subject was identified as an extreme value using the Tuckey Fences approach and was excluded from final analysis.

rSO2 - %saturation; Steady State rSO2 Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction after Equilibration for each Set Point

Outcome measures

Outcome measures
Measure	Varying Cerebral Oxygenation With Varying Ventilation n=9 Participants Compare oxygenation under conditions of varying ventilation strategy. Low end tidal CO2/Low inspired oxygen vs High end tidal CO2/high inspired oxygen IVOS cerebral oximeter: Measuring percutaneous cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction. Licox cerebral oxygenation monitor: Measuring tissue cerebral oxygenation secondary to changing end tidal carbon dioxide and inspired oxygen fraction. Cerebral oxygenation: Measuring cerebral oxygenation with varying ventilation strategy
Changes in rSO2 Resultant Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction Set Point 1 (FiO2 0.3 and PaCO2 30 mmHg)	68.0 percentage saturation Interval 62.5 to 80.5
Changes in rSO2 Resultant Upon Changes in End Tidal Carbon Dioxide and Inspired Oxygen Fraction Set Point 2 (FiO2 1.0 and PaCO2 40 mmHg)	83.0 percentage saturation Interval 74.0 to 90.0

Adverse Events

Varying Cerebral Oxygenation With Varying Ventilation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paul Picton

University of Michigan

Phone: 734 615 9864

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place