A New Technique for Determining Limb Occlusion Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 4
- 主要终点
- Limb Occlusion Pressure Measurement (mmHg) using the new technique and the gold-standard technique
研究概览
简要总结
This study evaluates a novel technique for measuring the minimum pressure necessary to achieve a bloodless surgical field, known as a patient's limb occlusion pressure (LOP). Patients will have tourniquets applied to their arms and legs and LOP will be measured using the new technique and a gold standard Doppler ultrasound technique.
详细描述
Optimal tourniquet safety depends on accurately determining the minimum pressure necessary to achieve a bloodless surgical field, known as a patient's limb occlusion pressure (LOP). However, LOP is not yet routinely measured in all patients due to limitations of current techniques. This study evaluates a novel technique for measuring the LOP through the tourniquet cuff that overcomes many limitations of current LOP measurement techniques.
The goal of the study is to determine if the LOP measured by the new technique is statistically or clinically different from the LOP measured by a gold standard Doppler ultrasound technique in adult and pediatric patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Scheduled for a visit to one of four surgical clinics in Vancouver, Canada
- •Agreed to participate in the study and provide informed consent
排除标准
- •Unable to give informed consent on their own behalf or by a legal guardian
- •Lack of parental agreement in the case of consent from a legally competent minor
- •Standard contraindications to tourniquet use
- •Vascular disease or circulation problems in the extremities
- •History or indication of deep vein thrombosis
研究组 & 干预措施
LOP Measurement
Measure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument and the gold-standard technique with the handheld Doppler ultrasound.
干预措施: Handheld Doppler ultrasound (Device)
LOP Measurement
Measure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument and the gold-standard technique with the handheld Doppler ultrasound.
干预措施: Personalized Tourniquet Instrument (Device)
结局指标
主要结局
Limb Occlusion Pressure Measurement (mmHg) using the new technique and the gold-standard technique
时间窗: at time of measurement
次要结局
- Limb Occlusion Pressure Measurement (mmHg) using the new technique and the existing distal sensor-based technique(at time of measurement)
研究者
James A. McEwen
Principal Investigator
University of British Columbia