NCT03584100

Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal

The Effect of Pneumatic Tourniquet Use on Upper Extremity Edema Following Axillary Lymph Node Dissection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Healthy Subject

Interventions

Type	Name	Description
DEVICE	Tourniquet 8000	Pneumatic tourniquet with appropriate upper extremity cuff, pressure sensing, and ability to set device at 40 mmHg of pressure

Timeline

• Start date: 2018-11-07
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2018-07-12
• Last updated: 2023-12-13
• Results posted: 2021-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study