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

Article

Charters, Brooke, Foster, Paed Acute, Lawton, Benjamin, Cassidy, Corey, Byrnes, Joshua, Mihala, Gabor, Schults, Jessica, Kleidon, Tricia, Mccaffery, Ruth, Van, Kristy and Ullman, Amanda. 2022. "On a quest to prevent harm and safeguard paediatric venous catheters – A randomized control trial protocol." Vascular Access. 16 (3), pp. 18-26.
Article Title

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

Article CategoryArticle
AuthorsCharters, Brooke, Foster, Paed Acute, Lawton, Benjamin, Cassidy, Corey, Byrnes, Joshua, Mihala, Gabor, Schults, Jessica, Kleidon, Tricia, Mccaffery, Ruth, Van, Kristy and Ullman, Amanda
Journal TitleVascular Access
Journal Citation16 (3), pp. 18-26
Number of Pages12
Year2022
PublisherCanadian Vascular Access Association
Place of PublicationCanada
Web Address (URL)https://cvaa.info/en/publications/vascular-access-journal
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.

Contains Sensitive ContentDoes not contain sensitive content
ANZSRC Field of Research 2020420501. Acute care
Byline AffiliationsSchool of Nursing and Midwifery
Metro South Hospital and Health Service, Queensland
Ipswich Hospital, Australia
Griffith University
Children’s Health Queensland Hospital and Health Service, Queensland
University of Queensland
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