The Influence of Perioperative Optimisation to the Primary Hip Arthroplasty Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- The efficiency of semi-closed loop infusion system
研究概览
简要总结
Success of the hip arthroplasty depends on the measures that optimize perioperative conditions.It is planned to evaluate semi-closed loop system in the hip arthroplasty surgery.
详细描述
Success of the total hip arthroplasty depends on the measures that optimize perioperative conditions. They increase the emotional stress of the staff and error probability. It is planned to evaluate semi-closed loop infusion system, its adaption for infusion application's influence to near and far treatment outcomes done by prospective randomized clinical trial. This is done by performing total hip arthroplasty. It's expected to evaluate the semi-closed loop system's influence on the doctor's emotional tension during the decision making.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with osteoarthritis of the hip undergoing hip arthroplasty with spinal - epidural anesthesia
- •Age >50 and <85 years
- •ASA (American Society of Anesthesiology Classification) II physical status
- •Start of operation no later than 09:00
- •Signed informed consent form
排除标准
- •Age <50 and >85 yers
- •BMI (Body Mass Index) <20 and >40 kg/m2
- •ASA I and ASA>II physical status
- •History of a bleeding disorder
- •Anemia before surgery Hb<110 g/l
- •Intravascular fluid infusion within 24 hours before study
- •Diabetes mellitus
- •Previous open hip surgery
- •Psychiatric illness (intake of other psychiatric medication than selective serotonin reuptake inhibitors)
- •Alcohol intake 5 U daily
- •Contraindication to spinal - epidural anesthesia
- •Surgery not by project surgeon
- •Start of operation later than 09:00
- •Atrial fibrillation
- •Narcotic addiction
- •History of DVT (Deep Vein Thrombosis), thromboembolic complications, acute cardiac insufficiency
- •Participation in the other study
结局指标
主要结局
The efficiency of semi-closed loop infusion system
时间窗: Before the surgery and 12 hrs postoperatively
Determine the ratio of doctor's approved and rejected computer suggestions
次要结局
- Dosage physical exercise sample(Within 6 days postoperatively)
- Perioperative blood loss(Before (baseline) the surgery,during surgery and 24hrs postoperatively)
- Coagulation activity(Before (baseline) the surgery and 24hrs postoperatively)
- Complications(Within 6 days postoperatively)
- Wound healing(Within 6 days postoperatively)
- Infused fluid and red blood cell volume(Before the surgery and 24hrs postoperatively)
- Haemodynamic stability(Before (baseline) the surgery and 12 hrs postoperatively)
研究者
Darius Cincikas
Audrius Andrijauskas PhD , principal investigator, clinical professor
Vilnius University