Recruiting

SmartFlow Compression

Sponsor:

Cardinal Health

Code:

NCT05945186

Conditions

Hemodynamics

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Intermittent Pneumatic Compression (IPC)(Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves)

Study Details

Brief summary:

This study is being conducted to evaluate the hemodynamic performance (i.e. flow of blood) in the legs using the new Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves.

Conditions

Hemodynamics

Study ID

NCT05945186

Start date

Aug, 2023

Status verified date

Jul, 2023

Completion date

Nov, 2023

Anticipated

Primary completion date

Oct, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Subject must be ≥18 years and ≤ 89 years of age.
  • Subject must be able to speak and read English.
  • Subject must have both legs fully intact (cannot be an amputee) with normal function.
  • Subject must be able to commit to the full study duration (approximately 1-2 hours of uninterrupted time).
  • Subject legs must fit into the provided knee length compression sleeves (<32").
  • Subject must give written informed consent.

Exclusion Criteria:

  • Subject is currently pregnant or breastfeeding.
  • Subject has a positive COVID history within the previous 6 months.
  • Subject presents with

  • - local leg condition with which the sleeves would interfere such as dermatitis, vein ligation (immediate post-operative), gangrene, recent skin graft, or any other open wound
  • - arteriosclerosis or other ischemic vascular diseases as indicated by absence of pedal pulses and/or history of intermittent claudication with positive pain response
  • - edema of legs or pulmonary edema from congestive heart failure
  • - deformity of the leg
  • - current Deep Vein Thrombosis as identified during baseline clinical screening
  • - recent or old Deep Vein Thrombosis as identified during baseline clinical screening
  • - reflux in the superficial or deep veins
  • - history of DVT/PE
  • - known May-Thurner Syndrome
  • Subject who, in the opinion of the investigator, is not an appropriate candidate for the study

Study Design

Enrollment

19 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Single Arm

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.

Interventions

Intermittent Pneumatic Compression (IPC)(Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves)

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).

Primary outcome measure

  • Blood Velocity [ Time Frame: baseline, +10 minutes ]
  • Time Average Mean Velocity [ Time Frame: baseline, +10 minutes ]

Central Contacts and Locations

Central contacts

Victoria Colasanto

508-618-3574victoria.colasanto@cardinalhealth.com

Locations

Jobst Vascular Institute

Recruiting

Toledo, Ohio, United States, 43606

More Information

Sponsor

Cardinal Health

Last update posted

Jul 14, 2023

Last verified

Jul, 2023

Keywords

  • Hemodynamics
  • Blood Flow

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cardinal Health on 2023-07-14.