Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is being conducted to evaluate the hemodynamic performance (i.e. flow of blood) in the legs using the new Kendall SCD SmartFlowâ„¢ compression system with Cardinal Health Element compression sleeves.
This study is being conducted to evaluate hemodynamic performance using the new Kendall SCD SmartFlowâ„¢ compression system with Cardinal Health Element compression sleeves. The study is intended to confirm the system's ability to increase venous blood flow over baseline as measured by blood velocity, time average mean velocity and total volume flow, in both the femoral and popliteal veins.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Baseline blood flow (hemodynamic) measurements will be obtained via ultrasound for all enrolled subjects. Following baseline measurements, compression will be applied and blood flow (hemodynamic) measurements will be repeated via ultrasound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Pneumatic Compression (IPC)(Kendall SCD SmartFlowâ„¢ compression system with Cardinal Health Element compression sleeves) | Device | External intermittent pneumatic compression (IPC) systems are applied to subject legs and comprise of a controller, associated tubing set and single patient use disposable leg sleeves. The disposable sleeves are latex free and contain air bladder(s) that are inflated by the controller to provide compression to the legs/feet. These devices are designed to increase venous blood flow in at risk patients in order to help prevent Venous ThromboEmbolism (VTE), including Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Velocity | Blood Velocity (Baseline, Peak) will be assessed via ultrasound in the popliteal and femoral veins. | baseline, +10 minutes |
| Time Average Mean Velocity | Time Average Mean Velocity (Baseline, Augmented) will be assessed via ultrasound in the popliteal and femoral veins. | baseline, +10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Total Volume Flow | Total Volume Flow (Baseline, Augmented) will be assessed via ultrasound in the popliteal and femoral veins. | baseline, +10 minutes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subject is currently pregnant or breastfeeding.
Subject has a positive COVID history within the previous 6 months.
Subject presents with
Subject who, in the opinion of the investigator, is not an appropriate candidate for the study
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria Colasanto | Contact | 508-618-3574 | victoria.colasanto@cardinalhealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Fedor Lurie | Jobst Vascular Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jobst Vascular Institute | Recruiting | Toledo | Ohio | 43606 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|