Non-invasive Venous Air Plethysmography Assessment of Venous Hemodynamics in Patients Suspected Deep Venous Obstruction Used in Conjunction With Intermittent Pneumatic Compression.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

The purpose of this research is to measure changes in venous blood flow with an air-filled bladder under an intermittent pneumatic compression device cuff (used to prevent deep venous thrombosis) or venous diagnostic device cuff (used to detect deep venous thrombosis). The devices being used in the study are investigational and not FDA-cleared.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Venous ultrasound study to evaluate for lower extremity DVT unilateral and/or bilateral within previous 72 hours.

Disqualifiers

Patients with inaccessible target limb (ultrasound limb) due to bandages (wound, burn, lesion, etc) or cast.

Patients with leg trauma, fracture, above or below knee amputation, or other condition in which compressing on the calf is medically inappropriate or not possible.

Patients unable to provide informed written consent.

Trial population

Subjects with venous ultrasound evaluation performed to rule out deep vein thrombosis

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Mayo Dopplex ABIlity

    Device

    Device used to measure lower extremity venous hemodynamic pressure

  • Intermittent Pneumatic Compression (IPC)

    Device

    Device used to measure lower extremity venous hemodynamic pressure

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Mayo Dopplex ABllity device Venous hemodynamic pressure

Venous hemodynamic pressure to be measured from both the recumbent and sitting positions using the Mayo Dopplex ABllity device. Measured as mmHg.

Time frame
Baseline
2

Intermittent Pneumatic Compression device Venous hemodynamic pressure

Venous hemodynamic pressure to be measured from both the recumbent and sitting positions using the IPC device. Measured as mmHg.

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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