The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes
- Conditions
- Hip Osteoarthritis
- Interventions
- Procedure: Semi-closed loop infusion system tactic.Procedure: Routine infusion therapy tactic
- Registration Number
- NCT03260309
- Lead Sponsor
- Vilnius University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description semi-closed system group Semi-closed loop infusion system tactic. Semi-closed loop infusion system tactic. Programmed iv fluid and blood infusion system ,,Belmont Rapid Infuser" and programmable syringe pump for adrenaline infusion. control group Routine infusion therapy tactic Routine infusion therapy tactic
- Primary Outcome Measures
Name Time Method The efficiency of semi-closed loop infusion system Before the surgery and 12 hrs postoperatively Determine the ratio of doctor's approved and rejected computer suggestions
- Secondary Outcome Measures
Name Time Method Perioperative blood loss Before (baseline) the surgery,during surgery and 24hrs postoperatively Non-invasive measurement of Hb (Masimo technology). Laboratory hemoglobin determination, evaluation of the bleeding volume
Coagulation activity Before (baseline) the surgery and 24hrs postoperatively Coagulation activity is investigated thromboelastically
Complications Within 6 days postoperatively Registration of all complications
Wound healing Within 6 days postoperatively Evaluation of wound tissue condition, measurement of drainage fluid volume
Dosage physical exercise sample Within 6 days postoperatively Timed up and go test
Infused fluid and red blood cell volume Before the surgery and 24hrs postoperatively Repeated rehydration bolus (sol.Ringeri 2,5ml/kg), supportive fluid infusion (sol.NaCl 0,9% 1,5 ml/kg/hrs); evaluation of signs of anemia intolerance if Hb \< 110 g/l
Haemodynamic stability Before (baseline) the surgery and 12 hrs postoperatively Invasive measurement of arterial blood pressure