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

Primary Purpose

Vascular Access Complication, Vascular Access Site Bruising

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound-guided vascular access
Sponsored by
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vascular Access Complication focused on measuring Ultrasound-guided vascular access, Randomized trial, Vascular access

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Other

    Arm Label

    Group A

    Group B

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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
    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.

    Full Information

    First Posted
    September 15, 2021
    Last Updated
    October 10, 2022
    Sponsor
    F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05156008
    Brief Title
    Comparison of Ultrasound-guided and Palpation-inserted Peripheral Venous Cannula
    Acronym
    CompOne
    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

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2023 (Anticipated)
    Study Completion Date
    January 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vascular Access Complication, Vascular Access Site Bruising
    Keywords
    Ultrasound-guided vascular access, Randomized trial, Vascular access

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Comparison of two arms. One arm ultrasound guided vascular access (UGVA) and control group standard vein cannulation with palpation.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    No Intervention
    Arm 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
    Arm Title
    Group B
    Arm Type
    Other
    Arm 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
    Intervention Type
    Other
    Intervention Name(s)
    Ultrasound-guided vascular access
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Ultrasound guided venous access need less attempts to successful cannulation
    Description
    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.
    Time Frame
    up to 24 hours
    Secondary Outcome Measure Information:
    Title
    Ultrasound guided venous access time to successful cannulation
    Description
    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.
    Time Frame
    up to 24 hours
    Title
    Venous access by palpation time to successful cannulation
    Description
    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.
    Time Frame
    up to 24 hours
    Title
    Ultrasound guided venous access allows insertion of cannulas suitable for blood drawing
    Description
    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.
    Time Frame
    up to 5 days
    Title
    UGVA will reduce the costs associated with perioperative venous access
    Description
    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.
    Time Frame
    up to 5 days
    Title
    Cannulas suitable for blood drawing, shortens the time a nurse spends drawing blood in the postoperative period at the ward
    Description
    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.
    Time Frame
    up to 5 days
    Title
    Insertion site infection occurrence after cannula placement
    Description
    In protocol there is mark using "madonn scale - peripheral cannulas site infection 0 - 4" for every day in cannula is in use
    Time Frame
    up to 5 days
    Title
    Long peripheral venous cannulas inserted under ultrasound guidance have low failure rate for intravenous therapy
    Description
    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.
    Time Frame
    through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Viktoria Durajova, Master, PhD
    Phone
    +421907312462
    Email
    vdurajova@nspbb.sk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michal Venglarcik, MD, PhD
    Phone
    +421903667096
    Email
    michal.venglarcik@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jakub Hlasny, MD
    Organizational Affiliation
    physician of anesthesia and intensive care department
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22137793
    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.
    Results Reference
    result
    PubMed Identifier
    26041384
    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.
    Results Reference
    result
    PubMed Identifier
    19925593
    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.
    Results Reference
    result
    PubMed Identifier
    18614482
    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.
    Results Reference
    result

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

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