Hip Osteoarthritis
Conditions
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.
Interventions
PROCEDURESemi-closed loop infusion system tactic.
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.
PROCEDURERoutine infusion therapy tactic
Routine re-hydration bolus before surgery. Routine treatment of hypotension. Routine treatment of anemia.
Sponsors
Karolinska Institutet
Kaunas University of Technology
Vilnius University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Coagulation activity | Before (baseline) the surgery and 24hrs postoperatively | Coagulation activity is investigated thromboelastically |
| 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 |
| Wound healing | Within 6 days postoperatively | Evaluation of wound tissue condition, measurement of drainage fluid volume |
| 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 |
| Haemodynamic stability | Before (baseline) the surgery and 12 hrs postoperatively | Invasive measurement of arterial blood pressure |
| Complications | Within 6 days postoperatively | Registration of all complications |
| Dosage physical exercise sample | Within 6 days postoperatively | Timed up and go test |
Outcome results
None listed