Comparison of Ultrasound-guided and Palpation-inserted Peripheral Venous Cannula (CompOne)

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Status: Not yet enrolling

Conditions: Vascular Access Complication; Vascular Access Site Bruising

Treatments: Other: Ultrasound-guided vascular access

Study type: Interventional

Funder types: Other

Identifiers

NCT05156008

26/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Group A

No Intervention group

Description:

Patient on the operating room, before primary hip or knee arthroplasty, will have his or her cannula inserted by standard palpation of vein under strict aseptic measures. Application of tourniquet on upper arm, palpation of vein, disinfection of skin and insertion of cannula. After two unsuccessful punctures, UGVA operator will step in and perform insertion of cannula with ultrasound. Medical staff will note: * number of attempts * time to obtain vascular access * type of cannula * DIVA score

Group B

Other group

Description:

Patient on the operating room, before primary hip or knee arthroplasty, will have his or her cannula inserted by ultrasound guided vascular access under strict aseptic measures. With or without tourniquet applied on upper arm operator will prescan vasculature of arm to choose applicable vein. After disinfection of skin optimal vein is on plain part of arm and cannula must not end in flection (elbow, wrist) of arm. Medical staff will note: * number of attempts, if 2 attempts fail, another operator will perform insertion * time to obtain vascular access * diameter of vein * type of cannula * DIVA score

Treatment:

Other: Ultrasound-guided vascular access