The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes

Hip Osteoarthritis Clinical Trial

Official title:

The Influence of Perioperative Optimisation to the Primary Hip Arthroplasty Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03260309
• Other study ID #: VilniusU
• Status: Completed
• Phase: N/A
• First received: February 29, 2016
• Last updated: August 25, 2017
• Start date: October 2013
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

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.
• Routine infusion therapy tactic
Routine re-hydration bolus before surgery. Routine treatment of hypotension. Routine treatment of anemia.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Vilnius University	Karolinska Institutet, Kaunas University of Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Coagulation activity	Coagulation activity is investigated thromboelastically	Before (baseline) the surgery and 24hrs postoperatively
Secondary	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
Secondary	Wound healing	Evaluation of wound tissue condition, measurement of drainage fluid volume	Within 6 days postoperatively
Secondary	Dosage physical exercise sample	Timed up and go test	Within 6 days postoperatively
Secondary	Haemodynamic stability	Invasive measurement of arterial blood pressure	Before (baseline) the surgery and 12 hrs postoperatively
Secondary	Complications	Registration of all complications	Within 6 days postoperatively