Poor Peripheral Perfusion
Conditions
Brief summary
Subjects' radial artery diameters and plethysmography waveforms will be recorded by MRI and pulse oxymetry at varying levels of radial artery compression by the Terumo TR Band.
Detailed description
In this study, the diameter of each subjects' radial artery will be measured using MRI imagery at varying degrees of radial artery compression by adjusting the amount of air injected into a Terumo TR Band. In addition, using pulse oxymetry, the perfusion waveform will be measured and recorded also while the subjects have a TR Band in place on their wrists.
Interventions
DEVICETR Band
The radial artery will be compressed using a Terumo TR Band and artery diameter and perfusion will be measured
Sponsors
Medical University of South Carolina
Terumo Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Female or male adult (has reached the legal majority age). 2. Subject has provided his/her written informed consent to participate in the trial prior to any study -related procedure being conducted.
Exclusion criteria
1. Abnormal result of either baseline Barbeau or reverse Barbeau tests. 2. Pregnant or breast feeding female. 3. Subject with contraindication to MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI Based Radial Artery Measurement | Subjects will be followed up to one week post procedure | Each subject's radial artery will be measured using MRI at varying levels of pressure within the TR Band. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hand Perfusion as Measured by Pulse Oxymetry Waveform | Subjects will be followed up to one week post procedure | pulse oxymetry waveform will be used to measure arterial perfusion |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TR Band MRI based Radial artery measurement | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | TR Band |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 25 years |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
MRI Based Radial Artery Measurement
Each subject's radial artery will be measured using MRI at varying levels of pressure within the TR Band.
Time frame: Subjects will be followed up to one week post procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TR Band | MRI Based Radial Artery Measurement | 1.35 millimeters |
Secondary
Hand Perfusion as Measured by Pulse Oxymetry Waveform
pulse oxymetry waveform will be used to measure arterial perfusion
Time frame: Subjects will be followed up to one week post procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TR Band | Hand Perfusion as Measured by Pulse Oxymetry Waveform | 50 percent saturated |