Trial Outcomes & Findings for Non-invasive Measurement of Cerebral Dynamic Autoregulation (NCT NCT02442856)

Results Overview

Rate of Regulation, measured using transcranial doppler. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

1.5 hours

Results posted on

2020-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention We will measure dynamic cerebral autoregulation (dCA) with both transcranial doppler (TCD) and diffuse correlation spectroscopy (DCS) during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=21 Participants We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.
Age, Continuous	31 years n=21 Participants
Sex: Female, Male Female	9 Participants n=21 Participants
Sex: Female, Male Male	12 Participants n=21 Participants

PRIMARY outcome

Timeframe: 1.5 hours

Population: 21 subjects consented, hemodynamic monitoring possible in 18. 1 subject did not tolerate,data acquisition was unsuccessful in 2. In 3 subjects, the pressure algorithm to isolate cerebral blood flow(CBF) was unsuccessful. In 4 subjects, BP did not decrease following cuff deflation due to technical issues leaving 11 subjects in the final analysis

Rate of Regulation, measured using transcranial doppler. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation.

Outcome measures

Outcome measures
Measure	Intervention n=11 Participants We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.
dCA Measurement During Acute Changes in Mean Arterial Pressure, TCD	0.262 per second Interval 0.17 to 0.366

PRIMARY outcome

Timeframe: 1.5 hours

Population: 21 subjects in the study, but hemodynamic monitoring was only possible in 18. 1 subject did not tolerate, and data acquisition was unsuccessful in 2. In 3 subjects, the pressure algorithm to isolate CBF was unsuccessful. In 4 subjects, BP did not decrease following cuff deflation due to technical issues leaving 11 subjects in the final analysis

Rate of Regulation, measured using diffuse correlation spectroscopy. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation.

Outcome measures

Outcome measures
Measure	Intervention n=11 Participants We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.
dCA Measurement During Acute Changes in Mean Arterial Pressure, Optical	0.278 per second Interval 0.199 to 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 1.5 hours

Linear relationship between Rate of Regulation measured using TCD and Optics, expressed as slope of linear fit

Outcome measures

Outcome measures
Measure	Intervention n=11 Participants We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.
Linear Relationship Between Rate of Regulation Measured Using TCD and Optics	0.96 slope

Adverse Events

Intervention

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

Michael Mullen

University of Pennsylvania

Phone: 215-662-3339

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place