Vascular Access Complication Clinical Trial
— CompOneOfficial title:
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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | January 15, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica |
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. — View 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. — View 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:a339. doi: 10.1136/bmj.a339. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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