Bleeding
Conditions
Keywords
Tourniquet, Muscle perfusion, Contrast ultrasound
Brief summary
The goal of this study is to use contrast enhanced ultrasound to determine the degree to which flow is reduced during application of a junctional tourniquet (JT). Contrast enhanced ultrasound is performed to quantify thigh and calf perfusion at baseline and during application of the JT
Interventions
DEVICEApplication of a Junctional Tourniquet
All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery.
Sponsors
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subject * Age 19-50
Exclusion criteria
* Peripheral artery disease * Known heart failure * Right to left shunt * Pregnancy * Presence of femoral artery aneurysm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Perfusion | baseline and 1 min post occlusion | Contrast ultrasound perfusion imaging will be performed at baseline and 1 min after application of the JT. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normal Subjects Normal subjects, all of whom undergo brief application of junctional tourniquet
Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Normal Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Muscle Perfusion
Contrast ultrasound perfusion imaging will be performed at baseline and 1 min after application of the JT.
Time frame: baseline and 1 min post occlusion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Subjects Baseline Flow | Muscle Perfusion | 0.32 IU/s | Standard Error 0.1 |
| Normal Subjects - Tourniquet Flow | Muscle Perfusion | 0.10 IU/s | Standard Error 0.03 |