Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy Subject

Intervention / Treatment
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* Device: Tourniquet 8000


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with prior axillary lymph node dissection<br>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. | Device: Tourniquet 8000<br>* Pneumatic tourniquet with appropriate upper extremity cuff, pressure sensing, and ability to set device at 40 mmHg of pressure<br>* Other names: Pneumatic tourniquet;|
| Active Comparator: Healthy Volunteers<br>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. | Device: Tourniquet 8000<br>* Pneumatic tourniquet with appropriate upper extremity cuff, pressure sensing, and ability to set device at 40 mmHg of pressure<br>* Other names: Pneumatic tourniquet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hand Volume Following Tourniquet Use | Hand volume, as an indicator of limb edema / fluid accumulation, was determined with an aqueous volumeter at rest and for the sling and elevated arm positions 30 minutes after an arm tourniquet was placed. Measurements were taken for the affected arm [ie, after axillary lymph node dissection (ALND)], and the same patient's contralateral arm (control, ie, other arm). The mean values for each arm (affected vs control) of the participant group, before (baseline) and 30 minutes after placement of the pneumatic tourniquet were obtained. The difference represents the effect of tourniquet placement. The outcome is reported as the overall mean difference in hand volume from baseline to 30 minutes after tourniquet placement for the ALND arm (affected arm) and the contralateral arm (control arm), with standard deviation. 12 patients only. | 30 minutes after tourniquet use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Hand Volume Following Tourniquet Use, Between ALND and Control Limbs | Hand volume, as an indicator of limb edema / fluid accumulation, was determined with an aqueous volumeter 30 minutes after an arm tourniquet was placed and the arm held in sling and elevated arm positions. Measurements were taken for the affected arm [ie, after axillary lymph node dissection (ALND)], and the same patient's contralateral arm (control, ie, other arm). Measurements were compared to the participant's contralateral control (the other arm) in the same positions. The difference represents to effect of ALND on hand volume. The outcome is reported as the absolute change in mean hand volume between the affected and control arms, a number without dispersion. | 30 minutes |