The Effect of Pneumatic Tourniquet Use on Upper Extremity Edema Following Axillary Lymph Node Dissection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Hand Volume Following Tourniquet Use
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have previously undergone axillary lymph node dissection
- •Or healthy volunteers
排除标准
- •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
结局指标
主要结局
Change in Hand Volume Following Tourniquet Use
时间窗: 30 minutes after 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.
次要结局
- Difference in Hand Volume Following Tourniquet Use, Between ALND and Control Limbs(30 minutes)
研究者
Jeffrey Yao, MD
Professor of Orthopaedic Surgery
Stanford University