Standard versUs peRForated peripheral intravenous catheter. The SURF trial: a pilot randomised controlled trial

INTERVENTION: Other than the study intervention, (type of peripheral intravenous catheter (PIVC) inserted), all other aspects of PIVC management will be as per local clinical guidelines (Royal Brisbane and Women’s Hospital, 000259: Peripheral Intravenous Cannulation and Infusion Management – Adult and Paediatrics). Hand hygiene is required prior to and throughout the insertion procedure. Skin will be prepped and decontaminated using a large swab or swab stick containing 2% Chlorhexidine Gluconate with 70% isopropyl alcohol. The antiseptic must be allowed to dry prior to inserting the IV catheter. Palpation of the insertion site should not be performed after the application of antiseptic, unless aseptic technique is maintained. If the health professional needs to re‐establish the identification of the vein, the site should be re‐prepped with the antiseptic solution and allowed to thoroughly dry. It is more efficient to assess the patient’s veins at the outset, determine degree of difficulty of insertion and then risk assess to ascertain if it may be more effective to wear sterile gloves to enable palpating of the cleansed area thereby maintaining Aseptic Non‐Touch Technique (ANTT®). Site selection will be determined by inserter following assessment of the patient’s vessel health and in consultation with radiographer/radiologist about procedure and infusion protocol. Study and control PIVCs will be inserted by trained clinicians (either clinical staff or research nurses), who are existing skilled or competent intravenous inserters. Pre‐trial they will have training and simulated practice inserting the study PIVC, until they feel confident that their skills match their competence for control PIVC insertion. If ultrasound is used to guide insertion, this will be recorded. Weekly checks by Research Nurse (ReN) for protocol fidelity will be conducted. A sterile transparent, semi‐permeable, self‐adhesive IV dressing must be placed over the insertion site (as per manufactu CONDITION: Anaesthesiology ‐ Anaesthetics vascular access failure (due to occlusion, infiltration, phlebitis, dislodgement);IV extravasation; ; vascular access failure (due to occlusion, infiltration, phlebitis, dislodgement) ; IV extravasation SECONDARY OUTCOME: Acceptable Image Quality. Study images will be assessed by a Radiologist to determine whether the image is of acceptable quality. Subjective image quality assessment for acceptability will be determined by: ; ; The report of the reading radiologist in the section of the report where the radiologist indicates if the image is acceptable or not. The absence of a comment in this section will be interpreted as acceptable.[measured at time of reporting on images] Adverse events such as infection or death. Clinical assessment will be performed daily and 48 hours after catheter removal. In addition, review of hospital records will be perform in case of death to determine if it was associated with the IV catheter.[During the the dwell of the catheter and up to 48 hours of catheter removal ; For participants whose IV catheter was removed overnight, review of the hospital records will be performed.[Clinical assessment will be performed daily and upon catheter removal. INCLUSION CRITERIA: greater than or equal to 18 years of age PIVC required for injection of contrast as part of Cancer Care diagnosis, prognosis, and/or treatment (outpatient or inpatient) PRIMARY OUTCOME: The primary outcome is PIVC failure (composite endpoint) for reasons of: occlusion, infiltration/extravasation, phlebitis/thrombophlebitis, dislodgement, haematoma, localised or bloodstream catheter‐related infections. a) Occlusion is defined as the inability to infuse or inject solution into a catheter. b) Infiltration/extravasation infiltration is defined as the inadvertent permeation of IV fluid (non‐vesicant solution) into the interstitial compartment, causing swelling of the tissue around the site of the catheter. Extravasation is the inadvertent administration of a vesicant solution into surrounding tissue. c) Phlebitis/thrombophlebitis phlebitis is defined as irritation and inflammation of a vein wall caused by the presence of the PIVC. It is characterised by the presence of any combination of tenderness, pain, erythema, swelling, warmth, palpable cord, or purulent drainage. In this study phlebitis includes pain (>1 out of 10) alone or plus any of the criteria mentioned above (on questioning, then palpation by the research nurse). Thrombophlebitis is also characterised by a visible clot on removal and/or palpable thrombosis of the cannulated vein. All these are consequence of the inflammation of the vein wall that leads to thrombus formation. In this study the presence of thrombophlebitis will be confirmed by ultrasound of the compromised vessel (if ordered by clinicians). d) Dislodgement is defined as movement of the catheter in and out of, or around and within, the vein resulting in partial or complete dislodgement. This may be characterized as Leaking (partial dislodgement). e) Haematoma is defined as solid swelling of clotted blood within the tissue, caused by a break in the wall of the blood vessel due to the insertion of a PIVC, resulting in device malfunction and triggering the removal of the catheter.' f) Localised venous infection is defined as organisms grown from purulent discharge or vein segment with no evidence of associated bloodstream infection. g) Bloodstream infection is defined as positive blood culture from a peripheral vein; clinical signs of infection (i.e. fever, chills, or hypotension); no other apparent source for the bloodstream infection except the intravenous catheter (in situ within 48 h of the bloodstream infection); and either a colonised intravenous catheter tip culture with the same organism as identified in the blood or purulent drainage from the involved vascular site.[Clinical assessment will be performed daily and upon catheter removal. A review of pathology results will be performed 48 hours after catheter removal.] The primary outcome Study feasibility: The feasibility outcome will be determined based on the following criteria:; i. Eligibility: over 90% of screened patients meeting all inclusion and no exclusion criteria;; ii. Recruitment: over 90% of eligible patients providing informed consent (or not opting out);; iii. Retention: fewer than 5% of recruited patients lost to follow up or withdrawing consent;; iv. Protocol fidelity: over 90% of randomised patients receiving their allocated intervention;; v. Missing data: less than 5% of primary endpoint data unable to be collected by study staff; and; vi. Patient and staff acceptability with the study intervention and control: 70% of patient/parents and staff scoring greater than or equal to 7 on a 0‐10 point rating scale at study completion.; [Feasibility outcomes calculated from trial screening logs and database. Protocol fidelity determined from weekly (observational) practice audit and verbal reports by staff. Staff will be invited for to give feedback at the end of the trial.] ; ] Device colonisation: Approximately 20 PIVCs (10 from each group) will be analysed by the semi‐quantitative method in the QUT QIMR laboratory. PIVCs will be selected based on availability of the Research Nurse when the PIVC is removed and when transfer to the lab is available. Colonisation of intravenous catheter tip will be considered if more than 15 colony‐forming units are present. Blood cultures from a peripheral vein, and PIVC skin swabs (if ordered by clinicians) will be cultured by Microbiology Pathology Queensland‐Central Lab by blinded scientists[24‐76 hours after catheter removal] Dwell time without complications. The Research Nurse will visit the participants once a day and perform a clinical assessment of the IV catheter, and record the information using ReDCap (Vanderbilt) software on hand‐held devices. ; ] Failure type (occlusion, infiltration/extravasation, phlebitis/thrombophlebitis, dislodgement, haematoma, localised or bloodstream catheter‐related infections)[Clinical assessment will be performed daily and upon catheter removal. A review of pathology results will be performed 48 hours after catheter removal.] first insertion success as a dichotomous variable (Yes/No) [measured at time of insertion] Insertion pain (NRS 0=no pain, 10=extreme pain)[Right after catheter insertion] number of PIVC insertion attempts by clinician inserting device measured as a continuous variable i.e. count of how many attempts were needed before successful placement of PIVC cannula achieved [measured at time of insertion or gathered retrospectively from medical record ]