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Completed

NCT Number: NCT03260309

The Influence of Perioperative Optimisation to the 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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semi-closed loop infusion system tactic.

Procedure

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

Procedure

Routine re-hydration bolus before surgery. Routine treatment of hypotension. Routine treatment of anemia.

Primary outcomes

  1. The efficiency of semi-closed loop infusion system

    Time frame: Before the surgery and 12 hrs postoperatively

    Determine the ratio of doctor's approved and rejected computer suggestions

Secondary outcomes

  1. Perioperative blood loss

    Time frame: Before (baseline) the surgery,during surgery and 24hrs postoperatively

    Non-invasive measurement of Hb (Masimo technology). Laboratory hemoglobin determination, evaluation of the bleeding volume

  2. Coagulation activity

    Time frame: Before (baseline) the surgery and 24hrs postoperatively

    Coagulation activity is investigated thromboelastically

  3. Infused fluid and red blood cell volume

    Time frame: 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

  4. Wound healing

    Time frame: Within 6 days postoperatively

    Evaluation of wound tissue condition, measurement of drainage fluid volume

  5. Dosage physical exercise sample

    Time frame: Within 6 days postoperatively

    Timed up and go test

  6. Haemodynamic stability

    Time frame: Before (baseline) the surgery and 12 hrs postoperatively

    Invasive measurement of arterial blood pressure

  7. Complications

    Time frame: Within 6 days postoperatively

    Registration of all complications

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Collaborators

  • Karolinska Institutet
  • Kaunas University of Technology

Registry information

Official study title

The Influence of Perioperative Optimisation to the Primary Hip Arthroplasty Outcomes

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 24, 2017
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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