The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes

Vilnius University

Status: Completed

Conditions: Hip Osteoarthritis

Treatments: Procedure: Semi-closed loop infusion system tactic.; Procedure: Routine infusion therapy tactic

Study type: Interventional

Funder types: Other

Identifiers

NCT03260309

VilniusU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

100 participants in 2 patient groups

semi-closed system group

Experimental group

Description:

Semi-closed loop infusion system tactic. Programmed iv fluid and blood infusion system ,,Belmont Rapid Infuser" and programmable syringe pump for adrenaline infusion.

Treatment:

Procedure: Semi-closed loop infusion system tactic.

control group

Experimental group

Description:

Routine infusion therapy tactic

Treatment:

Procedure: Routine infusion therapy tactic