Dataset Information

Integrated versus nonintegrated peripheral intravenous catheter in hospitalized adults (OPTIMUM): A randomized controlled trial.

ABSTRACT:

Background

One-third of peripheral intravenous catheters (PIVCs) fail from inflammatory or infectious complications, causing substantial treatment interruption and replacement procedures.

Objectives

We aimed to compare complications between integrated PIVCs (inbuilt extension sets, wings, and flattened bases) and traditional nonintegrated PIVCs.

Designs, settings and participants

A centrally randomized, controlled, superiority trial (with allocation concealment until study entry) was conducted in three Australian hospitals. Medical-surgical patients (one PIVC each) requiring intravenous therapy for >24 h were studied.

Main outcome measures

The primary outcome was device failure (composite: occlusion, infiltration, phlebitis, dislodgement, local, or bloodstream infection). Infection endpoints were assessor-masked. The secondary outcomes were: failure type, first-time insertion success, tip colonization, insertion pain, dwell time, mortality, costs, health-related quality of life, clinician, and patient satisfaction.

Results

Out of 1759 patients randomized (integrated PIVC, n = 881; nonintegrated PIVC, n = 878), 1710 (97%) received a PIVC and were in the modified intention-to-treat analysis (2269 PIVC-days integrated; 2073 PIVC-days nonintegrated). Device failure incidence was 35% (145 per 1000 device-days) nonintegrated, and 33% (124 per 1000 device-days) integrated PIVCs.

Intervention

Integrated PIVCs had a significantly lower failure risk (adjusted [sex, infection, setting, site, gauge] hazard ratio [HR]: 0.82 [95% confidence interval, CI: 0.69-0.96], p = .015). The per-protocol analysis was consistent (adjusted HR: 0.80 [95% CI: 0.68-0.95], p = .010). Integrated PIVCs had significantly longer dwell (top quartile ≥ 95 vs. ≥84 h). Mean per-patient costs were not statistically different.

Conclusions

PIVC failure is common and complex. Significant risk factors include sex, infection at baseline, care setting, insertion site, catheter gauge, and catheter type. Integrated PIVCs can significantly reduce the burden of PIVC failure on patients and the health system.

SUBMITTER: Rickard CM

PROVIDER: S-EPMC10099685 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

Integrated versus nonintegrated peripheral intravenous catheter in hospitalized adults (OPTIMUM): A randomized controlled trial.

Rickard Claire M CM Larsen Emily E Walker Rachel M RM Mihala Gabor G Byrnes Joshua J Saiyed Masnoon M Cooke Marie M Finucane Julie J Carr Peter J PJ Marsh Nicole N

Journal of hospital medicine 20221113 1

<h4>Background</h4>One-third of peripheral intravenous catheters (PIVCs) fail from inflammatory or infectious complications, causing substantial treatment interruption and replacement procedures.<h4>Objectives</h4>We aimed to compare complications between integrated PIVCs (inbuilt extension sets, wings, and flattened bases) and traditional nonintegrated PIVCs.<h4>Designs, settings and participants</h4>A centrally randomized, controlled, superiority trial (with allocation concealment until study ...[more]

PMID: 36372995

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Project description:INTRODUCTION:Peripheral intravenous catheters (PIVCs) are frequently used in hospitals. However, PIVC complications are common, with failures leading to treatment delays, additional procedures, patient pain and discomfort, increased clinician workload and substantially increased healthcare costs. Recent evidence suggests integrated PIVC systems may be more effective than traditional non-integrated PIVC systems in reducing phlebitis, infiltration and costs and increasing functional dwell time. The study aim is to determine the efficacy, cost-utility and acceptability to patients and professionals of an integrated PIVC system compared with a non-integrated PIVC system. METHODS AND ANALYSIS:Two-arm, multicentre, randomised controlled superiority trial of integrated versus non-integrated PIVC systems to compare effectiveness on clinical and economic outcomes. Recruitment of 1560 patients over 2 years, with randomisation by a centralised service ensuring allocation concealment. Primary outcomes: catheter failure (composite endpoint) for reasons of: occlusion, infiltration/extravasation, phlebitis/thrombophlebitis, dislodgement, localised or catheter-associated bloodstream infections. SECONDARY OUTCOMES:first time insertion success, types of PIVC failure, device colonisation, insertion pain, functional dwell time, adverse events, mortality, cost-utility and consumer acceptability. One PIVC per patient will be included, with intention-to-treat analysis. Baseline group comparisons will be made for potentially clinically important confounders. The proportional hazards assumption will be checked, and Cox regression will test the effect of group, patient, device and clinical variables on failure. An as-treated analysis will assess the effect of protocol violations. Kaplan-Meier survival curves with log-rank tests will compare failure by group over time. Secondary endpoints will be compared between groups using parametric/non-parametric techniques. ETHICS AND DISSEMINATION:Ethical approval from the Royal Brisbane and Women's Hospital Human Research Ethics Committee (HREC/16/QRBW/527), Griffith University Human Research Ethics Committee (Ref No. 2017/002) and the South Metropolitan Health Services Human Research Ethics Committee (Ref No. 2016-239). Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:ACTRN12617000089336.

Project description:ObjectivePeripheral intravenous catheter (PIVC) failure occurs frequently, but the underlying mechanisms of failure are poorly understood. We aim to identify ultrasonographic factors that predict impending PIVC failure prior to clinical exam.MethodsWe conducted a single site prospective observational investigation at an academic tertiary care center. Adult emergency department (ED) patients who underwent traditional PIVC placement in the ED and required admission with an anticipated hospital length of stay greater than 48 hours were included. Ongoing daily PIVC assessments included clinical and ultrasonographic evaluations. The primary objective was to identify ultrasonographic PIVC site findings associated with an increased risk of PIVC failure. The secondary outcome was to determine if ultrasonographic indicators of PIVC failure occurred earlier than clinical recognition of PIVC failure.ResultsIn July and August of 2020, 62 PIVCs were enrolled. PIVC failure occurred in 24 (38.71%) participants. Multivariate logistic regression demonstrated that the presence of ultrasonographic subcutaneous edema [AOR 7.37 (1.91, 27.6) p = 0.0030] was associated with an increased likelihood of premature PIVC failure. Overall, 6 (9.67%) patients had subcutaneous edema present on clinical exam, while 35 (56.45%) had subcutaneous edema identified on ultrasound. Among patients with PIVC failure, average time to edema detectable on ultrasound was 46 hours and average time to clinical recognition of failure was 67 hours (P = < 0.0001).ConclusionsPresence of subcutaneous edema on ultrasound is a strong predictor of PIVC failure. Subclinical subcutaneous edema occurs early and often in the course of the PIVC lifecycle with a predictive impact on PIVC failure that is inadequately captured on clinical examination of the PIVC site. The early timing of this ultrasonographic finding provides the clinician with key information to better anticipate the patient's vascular access needs. Further research investigating interventions to enhance PIVC survival once sonographic subcutaneous edema is present is needed.

Dataset Information

Integrated versus nonintegrated peripheral intravenous catheter in hospitalized adults (OPTIMUM): A randomized controlled trial.

Background

Objectives

Designs, settings and participants

Main outcome measures

Results

Intervention

Conclusions

Publications

Integrated versus nonintegrated peripheral intravenous catheter in hospitalized adults (OPTIMUM): A randomized controlled trial.

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