Investigating the Efficacy of Peripheral intravenous catheter (PIVC) insertion using Imaging technology compared to Combined palpation and visualization for first-time insertion success. The EPIC randomised controlled trial.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: Ultrasound‐guided PIVC insertion is the use of ultrasound to locate and select an appropriate vein, with the PIVC inserted under direct ultrasound visualization by advancing the needle into the vein whilst moving the ultrasound probe in the direction of needle advancement. The procedure takes approximately 10 minutes and is performed by specialist practitioners such as vascular access specialists, anaesthetists and paediatric registrars trained in this procedure. Protocol adherence will be monitored by the nurse assisting the procedure. CONDITION: Peripheral intravenous catheter insertion failure ; ; Peripheral intravenous catheter insertion failure Public Health ‐ Health service research PRIMARY OUTCOME: First time insertion success: The number of PIVCs successfully inserted on first needle puncture as evidenced by blood flashback and ability to infuse 2‐10mL (age appropriate) 0.9% sodium chloride without signs of swelling or pain at the insertion site.; This data will be collected on insertion and verified in the patient electronic medical record.[At conclusion of study participation] SECONDARY OUTCOME: blockage/occlusion (with or without leakage), unable to inject or aspirate from the device. This will be collected daily on purpose built data extraction form and obtained from patient medical records.[Data collected daily by the clinical research nurse until removal of PIVC] Device dwell‐time (time from insertion to removal, in hours) as recorded on purpose built data extraction form and patient medical records.[Collected at device removal ] Dislodgement (complete or partial), As determined by change in external device length at insertion site (inner catheter visible), however remains in the vein, Total ‐ device completely leaves the vein. As documented in patient medical record or purpose built data extraction form[Data collected daily by the clinical research nurse until removal of PIVC] Health care costs: Associated with insertion procedures including the cost of subsequent sequalae (eg. cost and number of products used, cost of treating complications, staff time for device insertion)[Collected at completion of intravenous therapy or treatment OR at resolution of complications that may arise. As recorded on purpose built data extraction form and in patient medical records.] Infection (laboratory confirmed local or primary bloodstream infection) . A laboratory confirmed blood stream infection (BSI) that is not secondary to an infection at another body site, with device in place for >2 calendar days on the day of the BSI (day of device placement being Day 1) and the device was in place on the date of the event or the day before, when all elements of Laboratory confirmed BSI, were first present together (see CDC NHSN for full criteria) confirmed by an infectious disease specialist using de‐identified clinical and microbiological data. ; This data will be collected on insertion and verified in patient electronic medical record. This outcome will be assessed for each participant[At successful insertion of PIVC or abandonment of the procedure. The procedure will be abandoned once escalated to the most experienced inserter and 6 failed attempts.] Total PIVC insertion failure: Proportion of PIVCs that are unable to be inserted and require alternative therapy as indicated by audit of study database[At successful insertion of PIVC or at conclusion of study participation ] INCLUSION CRITERIA: 1. Between 0‐ 365 days and 18 years of age 2. The treating team have indicated that the patient will require intravenous therapy 3. Informed consent to participate 4. Conscious for insertion of PIVC 5. Inpatient at Queensland Children's Hospital ; [Data collected daily by the clinical research nurse until removal of PIVC] infiltration/extravasation, movement of fluids in to the surrounding tissues will be assessed using visual assessment, documented in purpose built data extraction form and patient medical records[Data collected daily by the clinical research nurse until removal of PIVC] Number of additional devices required to complete treatment. This will be collected on purpose built data extraction form and documented in patient medical records..[Collected at completion of intravenous therapy or at study completion.] Number of times it was not possible to insert PIVC using randomised insertion technique, however use of alternate technique resulted in successful PIVC insertion as documented in data extraction form and patient medical records.[At successful insertion of PIVC or at conclusion of study participation.] Pain, Assess using visual analog scale (0‐10), documented on purpose built data extraction form and documented in patient medical record.[Data collected daily by the clinical research nurse until removal of PIVC] Patient or parent reported satisfaction regarding insertion procedure (measured immediately following insertion using a 0‐10 verbal rating scale) [Immediately following the successful insertion of PIVC or at conclusion of study participation. ] phlebitis (defined as 2 or more of pain, redness or swelling), This will be obtained from patient medical records and collected on purpose built data extraction form..[Data collected daily by the clinical research nurse until removal of PIVC] Post‐insertion failure: PIVC dysfunction resulting in device no longer being suitable for treatment. A composite measure of causes of post‐insertion failure including pain, infiltration/extravasation, blockage/occlusion (with or without leakage), phlebitis (pain, erythema), thrombosis (radiologically confirmed), dislodgement (complete or partial) or infection (laboratory confirmed local or primary bloodstream infection). This will be collected daily on purpose built data extraction form and obtained from patient medical records.[Collected at 48 hours following device removal] Time to initiation of treatment from when treatment is prescribed to first intravenous dose as documented in patient medical record.[Administration of first dose of IV medication following device insertion.] Time to insert device: from start of procedure (application of tourniquet), to successful insertion (instillation of 2‐10mL (age appropriate) 0.9% NaCl without any swelling at the site and application of dressing). This will be documented at time of insertion by nurse assisting and documented in patient medical record[At successful insertion of PIVC or conclusion of study participation ] Total number of PIVC insertion attempts (skin punctures) to successfully insert PIVC
Epistemonikos ID: d08fb46b63068b27cdab1c73daf1d1ebcfededa2
First added on: Aug 24, 2024