Comparison of Ultrasound-guided and Palpation-inserted Peripheral Venous Cannula

NCT05156008 | Unknown DMC

• 1 other identifier: 26/2021
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vascular Access Complication; Vascular Access Site Bruising

Keywords

Ultrasound-guided vascular access; Randomized trial; Vascular access

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Ultrasound guided venous access time to successful cannulation

  up to 24 hours

• Venous access by palpation time to successful cannulation

  up to 24 hours

• Ultrasound guided venous access allows insertion of cannulas suitable for blood drawing

  up to 5 days

• UGVA will reduce the costs associated with perioperative venous access

  up to 5 days

• Cannulas suitable for blood drawing, shortens the time a nurse spends drawing blood in the postoperative period at the ward

  up to 5 days

Study Arms (2)

Group A

NO INTERVENTION

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

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

Interventions

Ultrasound-guided vascular access OTHER

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.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary hip or knee arthroplasty
• BMI over 25

You may not qualify if:

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

Sponsors & Collaborators

• F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica: lead

Related Publications (5)

• 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.

  PMID: 22137793 RESULT

• 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.

  PMID: 26041384 RESULT

• 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.

  PMID: 19925593 RESULT

• 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.

  PMID: 18614482 RESULT

• Hlasny J, Alberty R, Hlavac M, Grgac I, Grey MT, Venglarcik M. Comparison of ultrasound-guided and palpation-inserted peripheral venous cannula in -patients before primary hip or knee arthroplasty: study protocol for a randomized controlled trial. Trials. 2023 Jul 21;24(1):467. doi: 10.1186/s13063-023-07459-x.

  PMID: 37480132 DERIVED

Study Officials

• Jakub Hlasny, MD

  physician of anesthesia and intensive care department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viktoria Durajova, Master, PhD

CONTACT

+421907312462; vdurajova@nspbb.sk

Michal Venglarcik, MD, PhD

CONTACT

+421903667096; michal.venglarcik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Comparison of two arms. One arm ultrasound guided vascular access (UGVA) and control group standard vein cannulation with palpation.

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: December 14, 2021
• Study Start: July 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: January 15, 2024
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share