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临床试验/NCT01442298
NCT01442298已完成不适用

A Comparison Between an Individual Low Tourniquet Pressure Versus a Standard Pressure During Total Knee Arthroplasty. A Randomized Controlled Study

Charlotta Olivecrona2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
164
试验地点
2
主要终点
Cuff pressure (mmHg)

研究概览

简要总结

The use of bloodless field is a helpful and important method in orthopedic surgery. The surgery can be done without interrupting bleedings, while keeping an exact overlook of the anatomy. However the method is not without risks, and complications of various kind may occur. One of the most important factors to minimise the risk of complications, is to keep the lowest possible cuff pressure. Previous electromyography (EMG) studies have indicated neuromuscular abnormalities after bloodless field among many patients which may lead to a prolonged rehabilitation period since they cause a postoperative weakness in the muscles. Although in these studies an unnecessary high tourniquet pressures were used and the EMG tests were made 6 weeks and 6 months after the surgery.

With today's demand for fast rehabilitation, there is a need for better knowledge if lower tourniquet pressure in bloodless field surgery may lead to less neuromuscular abnormalities.

Limb Occlusion Pressure (LOP) is the tourniquet cuff pressure required to occlude the blood flow. It accounts for a patients limb and vessel characteristics and the type and fit of the tourniquet cuff. The method has developed and is now simplified, by using an automatic (plethysmographic) sensor placed on the second toe on the involved limb, and after administration of anaesthesia, and immediately before limb preparation and draping it measures the limb occlusion pressure.

When surgery starts, the cuff is inflated again; plus a safety margin based on the LOP pressure measured. The LOP method is still rarely used it has been seen as difficult and time consuming.

The primary aim of this study is to investigate whether you can reduce the used tourniquet pressure with the new LOP measurement technique and still have a adequate bloodless field; and if this will lead to any clinical difference regarding postoperative pain. The secondary aim is to investigate the difference between the test groups concerning muscle function and wound healing and if these are remaining and of clinical importance. The third aim is to study how common neuromuscular abnormalities are after the use of bloodless field with lower cuff pressures and if there are any differences between the standard method and the LOP method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
— 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Planned for total knee arthroplasty in bloodless field
  • 75 year or younger

排除标准

  • Patients unable to read and understand Swedish
  • Systolic blood pressure over 200 mmHg and a girth of the thigh over 78 cm was excluded.

结局指标

主要结局

Cuff pressure (mmHg)

时间窗: participantswill be followed for the duration of hospital stay , an expected avarage of 4-5 days

For patients in the control group the tourniquet cuff pressure was based on the patient's systolic blood pressure and a margin that were decided by the surgeon. In the LOP group the tourniquet cuff pressure were decided by measurement of limb occlusion pressure (LOP) by using an automated photo plethysmographic sensor connected to a ATS 3000 tourniquet apparatus

Quality of bloodless field

时间窗: particpants will be followed for the duration of the hospital stay, an expected avarage of 4-5 days

Direct after surgery the surgeon rated the quality of bloodless fiels on a visual analog scale (VAS)

次要结局

  • Postoperative pain(The participants were followed daily during their hospital stay (4-5 days) and at the two months follow up after surgery)
  • Range of motion (ROM)(The participants were examined at third postoperative day and at the two months follow up after surgery)
  • Postoperative wound complications(The participants were examined at discharged (day 4 or 5 postoperatively) and at the two months follow up after surgery)
  • EMG/EnEG(Participans were examined day three and two months postoperatively)

研究者

发起方
Charlotta Olivecrona
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Charlotta Olivecrona

RN nurse, OR nurse

Karolinska Institutet

研究点 (2)

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