The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Influence of Perioperative Optimisation to the Primary Hip Arthroplasty Outcomes

Conditions
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Hip Osteoarthritis

Intervention / Treatment
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* Procedure: Semi-closed loop infusion system tactic.
* Procedure: Routine infusion therapy tactic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: semi-closed system group<br>Semi-closed loop infusion system tactic. Programmed iv fluid and blood infusion system ,,Belmont Rapid Infuser and programmable syringe pump for adrenaline infusion. | Procedure: Semi-closed loop infusion system tactic.<br>* Semi -closed loop infusion system tactic.Use volume loading test twice (before surgery and 12hrs postoperatively). Computer provides advisory hypotension treatment algorithm. Computer provides advisory anemia treatment algorithm. Programmed iv fluid and blood infusions system ,,Belmont Rapid Infuser and programmable syringe pump for adrenaline infusion.<br>|
| Experimental: control group<br>Routine infusion therapy tactic | Procedure: Routine infusion therapy tactic<br>* Routine re-hydration bolus before surgery. Routine treatment of hypotension. Routine treatment of anemia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficiency of semi-closed loop infusion system | Determine the ratio of doctor's approved and rejected computer suggestions | Before the surgery and 12 hrs postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood loss | Non-invasive measurement of Hb (Masimo technology). Laboratory hemoglobin determination, evaluation of the bleeding volume | Before (baseline) the surgery,during surgery and 24hrs postoperatively | 
| Coagulation activity | Coagulation activity is investigated thromboelastically | Before (baseline) the surgery and 24hrs postoperatively | 
| Infused fluid and red blood cell volume | 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 | Before the surgery and 24hrs postoperatively | 
| Wound healing | Evaluation of wound tissue condition, measurement of drainage fluid volume | Within 6 days postoperatively | 
| Dosage physical exercise sample | Timed up and go test | Within 6 days postoperatively | 
| Haemodynamic stability | Invasive measurement of arterial blood pressure | Before (baseline) the surgery and 12 hrs postoperatively | 
| Complications | Registration of all complications | Within 6 days postoperatively |