The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes

The Influence of Perioperative Optimisation to the Primary Hip Arthroplasty Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Procedure: Semi-closed loop infusion system tactic.; Procedure: Routine infusion therapy tactic

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: semi-closed system group; 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.; 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.
Experimental: control group; Routine infusion therapy tactic	Procedure: Routine infusion therapy tactic; Routine re-hydration bolus before surgery. Routine treatment of hypotension. Routine treatment of anemia.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vilnius University
• Collaborators: Karolinska Institutet; Kaunas University of Technology
• Investigators: Principal Investigator: Andrijauskas Audrius, PhD, Vilnius University

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: February 29, 2016
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 25, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: VilniusU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided