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The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes

25. august 2017 opdateret af: Darius Cincikas, Vilnius University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Eksperimentel: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The efficiency of semi-closed loop infusion system
Tidsramme: Before the surgery and 12 hrs postoperatively
Determine the ratio of doctor's approved and rejected computer suggestions
Before the surgery and 12 hrs postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Perioperative blood loss
Tidsramme: Before (baseline) the surgery,during surgery and 24hrs postoperatively
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
Tidsramme: Before (baseline) the surgery and 24hrs postoperatively
Coagulation activity is investigated thromboelastically
Before (baseline) the surgery and 24hrs postoperatively
Infused fluid and red blood cell volume
Tidsramme: 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
Before the surgery and 24hrs postoperatively
Wound healing
Tidsramme: Within 6 days postoperatively
Evaluation of wound tissue condition, measurement of drainage fluid volume
Within 6 days postoperatively
Dosage physical exercise sample
Tidsramme: Within 6 days postoperatively
Timed up and go test
Within 6 days postoperatively
Haemodynamic stability
Tidsramme: Before (baseline) the surgery and 12 hrs postoperatively
Invasive measurement of arterial blood pressure
Before (baseline) the surgery and 12 hrs postoperatively
Complications
Tidsramme: Within 6 days postoperatively
Registration of all complications
Within 6 days postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vilnius University

Samarbejdspartnere

Karolinska Institutet
Kaunas University of Technology

Efterforskere

  • Ledende efterforsker: Andrijauskas Audrius, PhD, Vilnius University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2013

Primær færdiggørelse (Faktiske)

1. juni 2017

Studieafslutning (Faktiske)

1. juli 2017

Datoer for studieregistrering

Først indsendt

29. februar 2016

Først indsendt, der opfyldte QC-kriterier

21. august 2017

Først opslået (Faktiske)

24. august 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. august 2017

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VilniusU

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Uafklaret

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hofteartrose

Kliniske forsøg med Semi-closed loop infusion system tactic.

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Netherlands

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner