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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Access Complication; Vascular Access Site Bruising
• Intervention / Treatment: Other: Ultrasound-guided vascular access

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Viktoria Durajova, Master, PhD; Phone Number: +421907312462; Email: vdurajova@nspbb.sk
• Study Contact Backup: Name: Michal Venglarcik, MD, PhD; Phone Number: +421903667096; Email: michal.venglarcik@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A; 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
Other: Group B; 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	Other: Ultrasound-guided vascular access; Patients in this arm will have peripheral venous cannula inserted under realtime ultrasound guidance. Out of plane technique (in plane technique if too deep when tip of the needle is on vessel wall) used by experienced physicians in UGVA. Out of plane technique strictly used in step by step manner. That means moving probe with the tip of the needle to always locate its exact position, all the way into the vein. All performed insertions are carried out by skilled operators in UGVA with out of plane technique. Just before surgery in block room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound guided venous access need less attempts to successful cannulation	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.	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound guided venous access time to successful cannulation	Time measurement starts when operator puts probe on patient and starts prescan of veins. Time measurement stops when cannula is successfully inserted confirmed by blood return after removal of internal metal piece. Is measured in minutes and seconds.	up to 24 hours
Venous access by palpation time to successful cannulation	Time measurement starts when nurse or physician starts to assess veins. Tourniquet application, disinfection of skin, palpation and cannulation are considered as process of cannulation. Time measurement stops when cannula is successfully inserted confirmed by blood return after removal of internal metal piece. Is measured in minutes and seconds.	up to 24 hours
Ultrasound guided venous access allows insertion of cannulas suitable for blood drawing	During UGVA measurement of vein diameter measurement is mandatory. If diameter of vein in millimeters is equal to higher to Fr of catheter/cannula it should allow to draw blood without need for repeated vein punctures for blood sampling. Cannula G22 need 2,7mm vein diameter, Cannula G20 need 3,3mm vein diameter. Cannula G18 need 3,9mm vein diameter. In protocol there is mark on every day that cannula allows blood drawing. Is marked as yes-no immediately after insertion, and than every day until removal of cannula.	up to 5 days
UGVA will reduce the costs associated with perioperative venous access	In protocol there is mark for every material associated with blood drawing, venous access. After 5 days there will be sum of cost of material used. Up to 5 days or patient discharge.	up to 5 days
Cannulas suitable for blood drawing, shortens the time a nurse spends drawing blood in the postoperative period at the ward	Every need of blood draw is marked in protocol, time spend to draw blood is marked in protocol. Measured in minutes and seconds. There are to scenarios. Blood draw through cannula: Measurement starts the moment nurse applies flush of saline, after that nurse will draw blood according to protocol, time measurement stops when saline flush is administered after successful blood draw. If not successful then measurement continues through blood draw by venipuncture. Scenario two: blood draw through venipuncture: time measurement starts when nurse starts to assess veins for venipuncture. Time measurement stops after successful blood draw and after venipuncture site covering with tampon and tape.	up to 5 days
Insertion site infection occurrence after cannula placement	In protocol there is mark using "madonn scale - peripheral cannulas site infection 0 - 4" for every day in cannula is in use	up to 5 days
Long peripheral venous cannulas inserted under ultrasound guidance have low failure rate for intravenous therapy	Inability to administer intravenous therapy through cannula from any reason is considered as failure of cannula. Failure rate is calculated from ratio of cannulas that did not fail to cannulas that failed. Is marked in results as percentage (%) as whole number and two decimals.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
• Investigators: Principal Investigator: Jakub Hlasny, MD, physician of anesthesia and intensive care department

Publications and helpful links

General Publications

• 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.
• 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.
• Ahlqvist M, Berglund B, Nordstrom G, Klang B, Wirén 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): January 15, 2024

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Randomized trial; Ultrasound-guided vascular access; Vascular access
• Additional Relevant MeSH Terms: Wounds and Injuries; Wounds, Nonpenetrating; Contusions
• Other Study ID Numbers: 26/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No