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Randomized Controlled Trial
. 2024 May 1;178(5):437-445.
doi: 10.1001/jamapediatrics.2024.0167.

Novel Peripheral Intravenous Catheter Securement for Children and Catheter Failure Reduction: A Randomized Clinical Trial

Brooke Charters  1   2   3 , Kelly Foster  3 , Benjamin Lawton  1 , Leonard Lee  4   5 , Joshua Byrnes  6 , Gabor Mihala  6   7 , Corey Cassidy  8   9 , Jessica Schults  4   5   10 , Tricia M Kleidon  4   5   7 , Ruth McCaffery  8 , Kristy Van  1 , Vanessa Funk  1   11 , Amanda Ullman  4   5   7
Affiliations
Randomized Controlled Trial

Novel Peripheral Intravenous Catheter Securement for Children and Catheter Failure Reduction: A Randomized Clinical Trial

Brooke Charters et al. JAMA Pediatr. .

Abstract

Importance: Peripheral intravenous catheters (PIVCs) facilitate essential treatment. Failure of these essential devices is frequent and new securement strategies may reduce failure and improve patient outcomes.

Objective: To evaluate clinical effectiveness of novel PIVC securement technologies for children to reduce catheter failure.

Design, setting, and participants: A 3-arm, parallel group, superiority randomized clinical trial was conducted at 2 regional Australian hospitals from February 5, 2020, to January 14, 2022. Children aged 6 months to 8 years who were anticipated to require admission with a PIVC for at least 24 hours of in hospital treatment were eligible. Data were analyzed from May 25, 2022, to February 20, 2024.

Interventions: Participants were randomly allocated in a 1:1:1 ratio to standard care, bordered polyurethane (Tegaderm [3M]), integrated securement dressing (SorbaView SHIELD [Medline]), and integrated securement dressing with tissue adhesive (Secureport IV). One catheter was studied per patient.

Main outcomes and measures: Primary outcome was PIVC failure, defined as premature cessation of PIVC function for any reason prior to completion of planned treatment. Secondary outcomes were PIVC complications (any time dislodgement, occlusion, infiltration, partial dislodgement, extravasation, device leaking, phlebitis, pain), PIVC longevity, intervention acceptability (clinicians, participants, caregivers; 0-10 scale), and pain on removal (participants and caregivers; 0-10 scale relevant to age), adverse events, and health care costs.

Results: A total of 383 patients (51% female; median age 36 [25th-75th percentiles, 22-72] months) were randomized 134 to standard care, 118 to integrated securement dressing, and 131 to integrated securement dressing with tissue adhesive. PIVC failure was lowest in integrated securement dressing with tissue adhesive (15 [12%]; adjusted hazard ratio [aHR], 0.47; 95% CI, 0.26-0.84) compared with integrated securement dressing (24 [21%]; aHR, 0.78; 95% CI, 0.47-1.28) and standard care (43 [34%]). Direct costs were significantly lower for integrated securement dressing with tissue adhesive (median, Australian dollars [A$], 312 [A$1 is equal to $0.65 US dollars]; IQR, A$302-A$380) and integrated securement dressing (median, A$303; IQR, A$294-A$465) compared with standard care (median, A$341; IQR, A$297-A$592; P ≤ .002) when considering the economic burden related to failure of devices. PIVC longevity and intervention acceptability were similar across all groups.

Conclusions and relevance: In this study, PIVCs secured with integrated securement dressings and tissue adhesive, in comparison with standard care, bordered polyurethane dressings, were associated with significantly reduced PIVC failure, for children admitted to hospital via the emergency department. Further research should focus on implementation in inpatient units where prolonged dwell and reliable intravenous access is most needed.

Trial registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12619001026112.

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Conflict of interest statement

Conflict of Interest Disclosures: Ms Charters reported grants from the Emergency Medicine Foundation during the conduct of the study. Ms Foster reported grants from the Emergency Medicine Foundation during the conduct of the study. Dr Byrnes reported grants and employment from the Emergency Medicine Foundation during the conduct of the study; grants from Navi Medical Technologies, Abbott, and Edwards LifeSciences, and personal fees from 3M outside of the submitted work. Dr Mihala reported grants from the Emergency Medicine Foundation during the conduct of the study. Dr Cassidy reported grants from the Emergency Medicine Foundation during the conduct of the study. Dr Schults reported grants from Emergency Medicine Foundation. Ms Kleidon reported grants from Emergency Medicine Foundation during the conduct of the study; consultancy/educational lecture fees from 3M, Becton, Dickinson and Company, Braun, Medical Specialties Australia, and Smiths Medical outside the submitted work. Dr Ullman reported grants from the Emergency Medicine Foundation during the conduct of the study and grants from 3M outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram
ISD indicates integrated securement device; ITT, intention-to-treat; PIVC, peripheral intravenous catheter; TA, tissue adhesive.
Figure 2.
Figure 2.. Kaplan-Meier Curve of the Primary Outcome by Study Groups
X-axis truncated at 8 days due to relatively low numbers at risk. ISD indicates integrated securement device; TA, tissue adhesive
See this image and copyright information in PMC

Comment on

References

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