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Clinical Trials/NCT05156008
NCT05156008
Not yet recruiting
Not Applicable

Comparison of Ultrasound-guided and Palpation-inserted Peripheral Venous Cannula in Patients Before Primary Hip or Knee Arthroplasty a Randomized Controlled Trial

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica0 sites200 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vascular Access Complication
Sponsor
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Enrollment
200
Primary Endpoint
Ultrasound guided venous access need less attempts to successful cannulation
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

Every patient need venous access for surgery under anesthesia. It is the most frequently performed invasive procedure in medicine in the whole world. In expert groups, ultrasonographically guided vascular access (UGVA) appears to be a significantly better method, but studies on larger groups of patients are lacking.

Prospective randomized 2-arm study which is comparing success rate of ultrasound guided a palpation inserted cannulas in patients undergoing primary hip or knee arthroplasty.

The project will be managed according to the protocol of principles of Good Clinical Practice and valid regulations.

Detailed Description

More than 2 billion peripheral vascular cannulas (PVCs) are introduced globally each year. Each patient needs venous access for surgery under anesthesia. It is the most frequently performed invasive procedure in medicine in the whole world. Nevertheless, investigators still do not know how to fix them adequately, to work reliably for at least 72 hours. Then there is a group of patients with difficult intravenous access (DIVA). These patients often have to undergo repeated painful punctures through the skin when introducing PVC. Many times well trained healthcare worker in the ultrasound-guided vascular access is needed to introduce PVC in DIVA patients. Up to one third of adult patients are DIVA. In overweight orthopedic patients, this subpopulation can reach up to 50% . Up to 64% PVC fails within 72 hours. Several studies have shown that PVC introduced at the site of limb flexion (elbow, wrist), repeated punctures increase the risk of thrombosis, infection and phlebitis. In expert groups, ultrasonographically guided vascular access (UGVA) appears to be a significantly better method, but studies on larger groups of patients are lacking. Investigators hypothesise that UGVA is superior in many parameters. The aim of our study is to compare two types of cannula insertion methods and their benefits and risks for patients. Ultrasound guided insertion and palpation guided insertion. To have evidence robust enough and after statistical analysis investigators decided for sample of 500 patients. Investigators will evaluate data after 100, 250 and 500 patients. After statistical analysis will be calculate benefit/risk ratio for patients and take steps towards patient safety and satisfaction. The project will be managed according to the protocol of principles of Good Clinical Practice and valid regulations. Patients are divided in two groups. Group A (insertion by palpation of vein): standard cannula (name brand "vasofix" BBraun) insertion through vein palpation and insertion in block room. - prior insertion medical staff will fill in study protocol form A Group B (UGVA): DIVA score calculation, Ultrasound-guided (name brand "deep access introcan" BBraun) cannula insertion - prior insertion medical staff will fill in study protocol form B In primary outcome investigators hypothesised that UGVA need less attempts to successful cannulation in comparison with vein cannulation by palpation. Investigators also think that deep vein cannula secured by UGVA will have lower failure rates by any means. In general there are several benefits in UGVA. On the other hand all above is applicable only in hands of well trained medical staff.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
January 15, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Responsible Party
Principal Investigator
Principal Investigator

Jakub Hlasny, MD, EDRA

Principal investigator

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Eligibility Criteria

Inclusion Criteria

  • Primary hip or knee arthroplasty
  • BMI over 25

Exclusion Criteria

  • reoperation of endoprosthesis
  • mental disorder
  • age under 18
  • protocol non-compliance
  • gravidity
  • patient refusal or no informed consent or both

Outcomes

Primary Outcomes

Ultrasound guided venous access need less attempts to successful cannulation

Time Frame: up to 24 hours

Number of punctures through skin defines number of attempts. Every puncture of skin with cannula is considered as attempt. Number of attempts are recorded in protocol as whole number. Does not matter with technique is used.

Secondary Outcomes

  • Insertion site infection occurrence after cannula placement(up to 5 days)
  • Long peripheral venous cannulas inserted under ultrasound guidance have low failure rate for intravenous therapy(through study completion, an average of 1 year)
  • Venous access by palpation time to successful cannulation(up to 24 hours)
  • Cannulas suitable for blood drawing, shortens the time a nurse spends drawing blood in the postoperative period at the ward(up to 5 days)
  • Ultrasound guided venous access time to successful cannulation(up to 24 hours)
  • UGVA will reduce the costs associated with perioperative venous access(up to 5 days)
  • Ultrasound guided venous access allows insertion of cannulas suitable for blood drawing(up to 5 days)

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