Secure My Intravascular Line Effectively (SMILE): a pilot randomised controlled trial to evaluate an integrated securement device and tissue adhesive for peripheral intravenous catheters in paediatric patients

INTERVENTION: Patients in this study have peripheral venous catheters (PVC) used in paediatric medical, cardiac and surgical departments. Consenting participants (consent achieved from legal guardian) will have their PVC secured with either the interventions or control dressing and securements. This dressing and securement will be applied by either the Research Nurse or the treating clinician (dependent upon who inserts the PVC). Arm 1 (Control): Bordered Polyurethane Dressing. Bordered polyurethane dressings (BPUs) retain the central polyurethane component of standard polyurethane dressings with an added external adhesive border of foam or cloth fabric. Arm 2 (Intervention): Integrated Securement Device. An Integrated Securement Device is a polyurethane dressing which combines both SP (simple polyurethane) and SD (securement device) into one product. Arm 3: (Intervention): Tissue Adhesive (TA). TA is a medical grade 'superglue' (cyanoacrylate) used mainly to close skin lacerations/wounds as an alternative to sutures and staples. A bordered polyurethane dressing will also be applied. The randomly allocated dressing will be applied at the time of PVC insertion until device removal. There will be daily checks of the PVC site and dressings/securements to monitor protocol adherence and assess for any complications. CONDITION: Intravenous device failure prior to completion of therapy PRIMARY OUTCOME: All cause PVC failure A composite of infection (laboratory confirmed local or bloodstream infection), occlusion, dislodgement (complete or partial), phlebitis, infiltration or thrombosis (suspected or confirmed). This composite measure incorporates the multifocal path to the same endpoint; PVC failure. These will be assessed by either the Research Nurse (during daily checks); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record. The primary aim of this study is to pilot test the feasibility of a randomised trial that compares the effectiveness of new generation securement and dressing products for peripheral intravenous catheters. Feasibility measures will include: patient eligibility (more than 80% of those screened); consent (more than 80% agree to enrol); protocol adherence (more than 90% receive the allocated intervention); and retention (less than 5% of enrolled patients lost to follow up). Staff and patient acceptability of the intervention ‐ assessed on a 0‐10 Likert scale. SECONDARY OUTCOME: Adhesion: Is the dressing intact, lifting slightly or lifting a great deal. This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record. Dislodgement (either partial or total): ; Partial ‐ Change in PVC length at insertion site (inner catheter visible). This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record. ; Suspected ‐ This will be assessed by the treating clinician, recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record. ; Confirmed ‐ Ultrasound/venographic confirmed thrombosed vessel at the PVC site. This will be assessed by a review of the patient's medical records (including ultrasound findings). INCLUSION CRITERIA: 1. Informed written consent 2. PVC in situ 3. PVC scheduled/expected use >24 hours 4. Patient aged 18 years or less. 5, Patient admitted to a Medical, Cardiac or Surgical ward ; Total ‐ PVC completely leaves the vein. This will be recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record by the treating clinician. Infection (laboratory confirmed local or bloodstream infection): PVC skin and tip samples for culture may be collected by RNs upon PVC removal if clinical suspicion of local infection. Blood cultures may be be collected by RNs throughout the life of the device if clinical suspicion of systemic infection. Infiltration: Defined as pain, swelling and discomfort caused by IV fluids leaking into the tissues surrounding the PVC Occlusion: Defined as the PVC will not infuse, or leakage occurs when fluid is infused. Phlebitis: Defined as 2 or more of pain, redness, swelling and a palpable cord. This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record. PVC dwell time: Research staff will calculate time (in hours) from device insertion until removal using relevant information as recorded by clinical staff on a 1 page data collection sheet at the patients bedside and in the patients medical record. Safety and adverse events; Skin reactions related to dressings and securements will be monitored including itch; rash (raised or not raised); blistering; skin tearing; bruising; maceration, itching, and pressure areas. This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record. Staff and patient acceptability of the intervention ‐ assessed on a 0‐10 Likert scale. Thombosis (either suspected on confirmed):