Comparison of Ultrasound-guided and Palpation-inserted Peripheral Venous Cannula in Patients Before Primary Hip or Knee Arthroplasty a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Ultrasound guided venous access need less attempts to successful cannulation
研究概览
简要总结
Every patient need venous access for surgery under anesthesia. It is the most frequently performed invasive procedure in medicine in the whole world. In expert groups, ultrasonographically guided vascular access (UGVA) appears to be a significantly better method, but studies on larger groups of patients are lacking.
Prospective randomized 2-arm study which is comparing success rate of ultrasound guided a palpation inserted cannulas in patients undergoing primary hip or knee arthroplasty.
The project will be managed according to the protocol of principles of Good Clinical Practice and valid regulations.
详细描述
More than 2 billion peripheral vascular cannulas (PVCs) are introduced globally each year. Each patient needs venous access for surgery under anesthesia. It is the most frequently performed invasive procedure in medicine in the whole world. Nevertheless, investigators still do not know how to fix them adequately, to work reliably for at least 72 hours.
Then there is a group of patients with difficult intravenous access (DIVA). These patients often have to undergo repeated painful punctures through the skin when introducing PVC. Many times well trained healthcare worker in the ultrasound-guided vascular access is needed to introduce PVC in DIVA patients. Up to one third of adult patients are DIVA. In overweight orthopedic patients, this subpopulation can reach up to 50% . Up to 64% PVC fails within 72 hours.
Several studies have shown that PVC introduced at the site of limb flexion (elbow, wrist), repeated punctures increase the risk of thrombosis, infection and phlebitis. In expert groups, ultrasonographically guided vascular access (UGVA) appears to be a significantly better method, but studies on larger groups of patients are lacking.
Investigators hypothesise that UGVA is superior in many parameters. The aim of our study is to compare two types of cannula insertion methods and their benefits and risks for patients. Ultrasound guided insertion and palpation guided insertion. To have evidence robust enough and after statistical analysis investigators decided for sample of 500 patients.
Investigators will evaluate data after 100, 250 and 500 patients. After statistical analysis will be calculate benefit/risk ratio for patients and take steps towards patient safety and satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary hip or knee arthroplasty
- •BMI over 25
排除标准
- •reoperation of endoprosthesis
- •mental disorder
- •age under 18
- •protocol non-compliance
- •gravidity
- •patient refusal or no informed consent or both
结局指标
主要结局
Ultrasound guided venous access need less attempts to successful cannulation
时间窗: up to 24 hours
Number of punctures through skin defines number of attempts. Every puncture of skin with cannula is considered as attempt. Number of attempts are recorded in protocol as whole number. Does not matter with technique is used.
次要结局
- Insertion site infection occurrence after cannula placement(up to 5 days)
- Long peripheral venous cannulas inserted under ultrasound guidance have low failure rate for intravenous therapy(through study completion, an average of 1 year)
- Venous access by palpation time to successful cannulation(up to 24 hours)
- Cannulas suitable for blood drawing, shortens the time a nurse spends drawing blood in the postoperative period at the ward(up to 5 days)
- Ultrasound guided venous access time to successful cannulation(up to 24 hours)
- UGVA will reduce the costs associated with perioperative venous access(up to 5 days)
- Ultrasound guided venous access allows insertion of cannulas suitable for blood drawing(up to 5 days)
研究者
Jakub Hlasny, MD, EDRA
Principal investigator
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica