On a quest to prevent harm and safeguard paediatric venous catheters – A randomized control trial protocol

Abstract

Aim: This study will evaluate the most effective peripheral intravenous catheter securement in paediatric emergency departments to reduce catheter failure, healthcare costs, patient distress, and improve satisfaction. Design: A multisite, three-arm, parallel, superiority, randomized controlled trial of 506 children requiring peripheral intravenous catheter in the emergency department. The trial will be reported following CONSORT guidelines, is registered on the Australian New Zealand Clinical Trials Registry (ACTRN12619001026112) and ethics is approved via Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/19/QCHQ/45567). Methods: Staff screen patients, six months to eight years old, requiring peripheral intravenous catheters and inpatient stay of more than 24 hours. Written informed consent is obtained from the legal guardian with 1:1:1 randomization ratio allocation: 1. Standard care: Bordered polyurethane dressing (Tegaderm Advanced®; 3M) 2. Integrated dressing and securement: SorbaView SHIELD® (Centurion Medical Products) 3. Integrated dressing and securement with tissue adhesive: SorbaView SHIELD® (Centurion Medical Products) and Tissue Adhesive Secureport IVTM (Adhezion Biomedical) Primary outcome is peripheral intravenous catheter failure; secondary outcomes are peripheral intravenous catheter complications, pain and distress, healthcare costs, and staff satisfaction or acceptability. Intention-to-treat analysis of timeto-event data will be completed using adjusted Cox regression. Direct costs calculated from the hospital perspective and costeffectiveness analysis will estimate the incremental cost of each treatment option. Discussion: Most hospitalized children require a peripheral intravenous catheter, although persistent high rates of failure are recognized as a patient safety concern. The outcomes of this trial will directly inform clinical care for peripheral intravenous catheter securement in children in emergency departments. Charters1,2, RN, PG Paed Acute Care, Kelly Foster2 , MNRS, RN, Dip HS, PG Crit Care, PhD Candidate, Benjamin Lawton1 , BSc, MBCHB, FRACP, Mph, Corey Cassidy3 , BSc (Hons), MBBS (Hons), FACEM, Joshua Byrnes4 , BEcon, BComm, MEcon, MHealth Econ, PhD, Gabor Mihala4,5, MEng (Mech), Gcert (Biostat), PhD, Jessica Schults5-8, RN, PhD, Tricia Kleidon5,6,8, RN, MNSci (Nurse Prac.), PhD candidate, Ruth McCaffery3 , RN, Kristy Van9 , RN, MNrs, and Amanda Ullman5-8, RN, PhD