Clinical trial NCT05156008: Comparison of Ultrasound-guided and Palpation-inserted Peripheral Venous Cannula
Official title: Comparison of Ultrasound-guided and Palpation-inserted Peripheral Venous Cannula in Patients Before Primary Hip or Knee Arthroplasty a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vascular Access Complication
Vascular Access Site Bruising
Keywords: Ultrasound-guided vascular access
Randomized trial
Vascular access
Lead sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of two arms. One arm ultrasound guided vascular access (UGVA) and control group standard vein cannulation with palpation.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* Primary hip or knee arthroplasty
* BMI over 25

Exclusion Criteria:

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

Primary outcomes:
measure: Ultrasound guided venous access need less attempts to successful cannulation
timeFrame: up to 24 hours
Secondary outcomes:
measure: Ultrasound guided venous access time to successful cannulation
timeFrame: up to 24 hours
measure: Venous access by palpation time to successful cannulation
timeFrame: up to 24 hours
measure: Ultrasound guided venous access allows insertion of cannulas suitable for blood drawing
timeFrame: up to 5 days
measure: UGVA will reduce the costs associated with perioperative venous access
timeFrame: up to 5 days
measure: Cannulas suitable for blood drawing, shortens the time a nurse spends drawing blood in the postoperative period at the ward
timeFrame: up to 5 days
measure: Insertion site infection occurrence after cannula placement
timeFrame: up to 5 days
measure: Long peripheral venous cannulas inserted under ultrasound guidance have low failure rate for intravenous therapy
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: physician of anesthesia and intensive care department
name: Jakub Hlasny, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Witting MD. IV access difficulty: incidence and delays in an urban emergency department. J Emerg Med. 2012 Apr;42(4):483-7. doi: 10.1016/j.jemermed.2011.07.030. Epub 2011 Dec 2.
citation: Alexandrou E, Ray-Barruel G, Carr PJ, Frost S, Inwood S, Higgins N, Lin F, Alberto L, Mermel L, Rickard CM. International prevalence of the use of peripheral intravenous catheters. J Hosp Med. 2015 Aug;10(8):530-3. doi: 10.1002/jhm.2389. Epub 2015 Jun 3.
citation: Ahlqvist M, Berglund B, Nordstrom G, Klang B, Wiren M, Johansson E. A new reliable tool (PVC assess) for assessment of peripheral venous catheters. J Eval Clin Pract. 2010 Dec;16(6):1108-15. doi: 10.1111/j.1365-2753.2009.01278.x.
citation: Webster J, Clarke S, Paterson D, Hutton A, van Dyk S, Gale C, Hopkins T. Routine care of peripheral intravenous catheters versus clinically indicated replacement: randomised controlled trial. BMJ. 2008 Jul 8;337(7662):a339. doi: 10.1136/bmj.a339.