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Randomized Controlled Trial
. 2023 Nov 1;177(11):1132-1140.
doi: 10.1001/jamapediatrics.2023.3526.

Midline Compared With Peripheral Intravenous Catheters for Therapy of 4 Days or Longer in Pediatric Patients: A Randomized Clinical Trial

Tricia M Kleidon  1   2   3   4 , Victoria Gibson  1   2   3 , Paula Cattanach  1   3 , Jessica Schults  1   2   3   4   5 , Ruth H Royle  6   7 , Robert S Ware  6 , Nicole Marsh  2   3   4   5   6 , Colleen Pitt  1   3 , Anna Dean  1   3 , Joshua Byrnes  6   7 , Claire M Rickard  2   3   4   5 , Amanda J Ullman  1   2   3   4
Affiliations
Randomized Controlled Trial

Midline Compared With Peripheral Intravenous Catheters for Therapy of 4 Days or Longer in Pediatric Patients: A Randomized Clinical Trial

Tricia M Kleidon et al. JAMA Pediatr. .

Abstract

Importance: Peripheral intravenous catheters (PIVCs) frequently fail during treatment causing therapy interruption, pain, recatheterization, and additional health care costs. Midline catheters (MCs) may improve functional dwell time and reduce failure compared with traditional PIVCs.

Objective: To compare device failure of MCs with PIVCs.

Design, setting, and participants: This was a pragmatic, randomized clinical superiority trial with an embedded internal pilot study conducted from July 2020 to May 2022. The study took place in a quaternary pediatric hospital in Brisbane, Queensland, Australia. Inclusion criteria were patients aged 1 to 18 years requiring peripherally compatible intravenous therapy for 4 days or longer.

Interventions: Patients were randomly assigned 1:1 to receive a PIVC or MC, stratified by age (≤5 years, >5 years). One catheter was studied per patient.

Main outcomes and measures: The primary outcome was all-cause device failure, defined as premature cessation of device function. Secondary outcomes included number of insertion attempts, insertion failure, pain (on insertion), procedural time, patient/parent satisfaction (with insertion), device dwell time, device complications during dwell time, additional vascular access devices required to complete treatment, clinician satisfaction (at removal), and health care costs.

Results: Of the 128 patients randomly assigned to study groups, 127 patients (median [IQR] age, 7 [2-13] years; 71 male [56%]) had a device inserted, with 65 (51.2%) in the PIVC group and 62 (48.8%) in the MC group. All patients were included in the intention-to-treat analysis. Device failure was lower in patients in the MC group (10 [16.1%]) compared with those in the PIVC group (30 [46.2%]; odds ratio [OR], 0.22; 95% CI, 0.10-0.52; P <.001). MCs were associated with fewer insertion attempts (mean difference [MD], -0.3; 95% CI, -0.5 to 0; P = .04), increased dwell time (MD, 66.9 hours; 95% CI, 36.2-97.5 hours; P <.001), and fewer patients required additional vascular access devices to complete treatment in the MC group (4 [6.5%]) and PIVC group (19 [29.2%]; OR, 0.17; 95% CI, 0.05-0.52; P = .002). Compared with PIVCs, use of MCs was associated with greater patient (9.0 vs 7.1 of 10; P = .002) and parent (9.1 vs 8.2 of 10; P = .02) satisfaction and lower health care costs (AUS -$151.67 [US -$101.13] per person; 95% credible interval, AUS -$171.45 to -$131.90 [US -$114.20 to -$87.95]).

Conclusions and relevance: Findings suggest that MC insertion for patients requiring peripherally compatible intravenous therapy for 4 days or longer should be prioritized to reduce the resource intensive, expensive, and burdensome sequelae of device failure.

Trial registration: Australia New Zealand Clinical Trials Registry, ACTRN12620000724976.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Kleidon reported receiving consultant/lecture fees and grants from 3M, BD/Bard, and B. Braun; consultant/lecture fees from Medical Specialties Australia, and consultant fees from Smiths Medical outside the submitted work. Dr Marsh reported receiving grants from Becton Dickinson, Eloquest Healthcare, 3M, and Cardinal Health and lecture fees from 3M outside the submitted work. Dr Byrnes reported receiving consultant/advisory fees from 3M and NeoNav and grants from Becton Dickinson/Bard outside the submitted work. Dr Rickard reported receiving grants from 3M, Cardinal Health, and Eloquest and consultant/advisory fees from 3M, Becton Dickinson, ITL Biomedical, and B. Braun outside the submitted work. Dr Ullman reported receiving grants from Becton Dickinson, 3M, and the National Health and Medical Research Council outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Consolidated Standards of Reporting Trials (CONSORT) Flow Diagram
PIVC indicates peripheral intravenous catheter. aIndicates participant was excluded from the analysis.
Figure 2.
Figure 2.. Kaplan-Meier Curve of Device Failure
PIVC indicates peripheral intravenous catheter.
See this image and copyright information in PMC

References

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