Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal

Stanford University

Status: Completed

Conditions: Healthy Subject

Treatments: Device: Tourniquet 8000

Study type: Interventional

Funder types: Other

Identifiers

NCT03584100

IRB-40228

BRS0075 (Other Identifier)

NCI-2018-01125 (Registry Identifier)

Details and patient eligibility

About

The purpose of the proposed study is to evaluate the acute impact of swelling caused by low-pressure tourniquet use in the setting of ipsilateral prior axillary lymph node dissection and the change in swelling reduction following tourniquet use in three limb postures versus healthy volunteers.

Full description

PRIMARY OBJECTIVES:

I. To evaluate reduction in swelling and safety of tourniquet use in patients with prior axillary lymph node dissection

OUTLINE:

Participants raise their arm for 15 minutes, then wear a tourniquet inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position.

PROCEDURE:

Participants raise their arm for 15 minutes, then wear a tourniquet 8000 inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position.

Enrollment: 12 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Have previously undergone axillary lymph node dissection
• Or healthy volunteers

Exclusion criteria

• Have new-onset lymphedema of the involved limb.
• Infection including cellulitis
• Trauma or planned axillary surgery within 6 months of participation
• Any prior axillary radiation

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Patients with prior axillary lymph node dissection

Experimental group

Description:

Participants raise their arm for 15 minutes, then wear a tourniquet 8000 inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position.

Treatment:

Device: Tourniquet 8000

Healthy Volunteers

Active Comparator group

Description:

Participants raise their arm for 15 minutes, then wear a tourniquet 8000 inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position.

Treatment:

Device: Tourniquet 8000