Comparing the use of midline catheters versus peripherally inserted central catheters for patients requiring peripherally compatible therapies: A pilot randomised controlled trial (the compact trial)

IF 2.7 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Infection Disease & Health Pub Date : 2023-11-01 DOI:10.1016/j.idh.2023.03.007
Nicole Marsh , Emily N. Larsen , Catherine O'Brien , Peter Groom , Tricia M. Kleidon , Evan Alexandrou , Emily Young , Kate McCarthy , Claire M. Rickard
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引用次数: 0

Abstract

Background

Midline catheter (MC) use has increased in acute-care settings, particularly for patients with difficult venous access or requiring peripherally compatible intravenous therapy for up-to 14 days. Our aim was to assess feasibility and generate clinical data comparing MCs with Peripherally Inserted Central Catheters (PICCs).

Methods

A two-arm parallel group pilot randomised controlled trial (RCT), comparing MCs with PICCs, was conducted in a large tertiary hospital in Queensland between September 2020 and January 2021. The primary outcome was study feasibility, measured against rates of eligibility (>75%), consent (>90%), attrition (<5%); protocol adherence (>90%) and missing data (<5%). The primary clinical outcome was all-cause device failure.

Results

In total, 25 patients were recruited. The median patient age was 59–62 years; most patients were overweight/obese, with ≥2 co-morbidities. Primary outcomes: The eligibility and protocol adherence criteria were not met; of 159 screened patients, only 25 (16%) were eligible, and three patients did not receive their allocated intervention post-randomisation (88% adherence). All-cause failure occurred in two patients allocated to MC (20%) and one PICC (8.3%).

Conclusions

Our study found that a fully powered RCT testing MCs compared with PICCs is not currently feasible in our setting. We recommend a robust process evaluation before the introduction of MCs into clinical practice.

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需要外周相容性治疗的患者使用中线导管与外周插入中心导管的比较:一项先导随机对照试验(紧凑型试验)。
背景:中线导管(MC)在急性护理环境中的使用有所增加,尤其是对于静脉通路困难或需要外周兼容静脉治疗长达14天的患者。我们的目的是评估MCs与外周插入中心导管(PICCs)的可行性并生成比较临床数据。方法:2020年9月至2021年1月,在昆士兰的一家大型三级医院进行了一项双臂平行组试点随机对照试验(RCT),比较MCs与PICCs。主要结果是研究的可行性,根据合格率(>75%)、同意率(>90%)、,损耗(90%)和数据缺失(结果:总共招募了25名患者。患者的中位年龄为59-62岁;大多数患者超重/肥胖,合并症≥2例。主要结果:不符合资格和方案遵守标准;在159名筛查患者中,只有25名(16%)符合资格,三名患者在随机化后没有接受分配的干预(88%的依从性)。两名MC患者(20%)和一名PICC患者(8.3%)发生了全因衰竭。结论:我们的研究发现,在我们的环境中,与PICC相比,全功率RCT测试MC目前是不可行的。我们建议在将MCs引入临床实践之前进行稳健的过程评估。
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来源期刊
Infection Disease & Health
Infection Disease & Health PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-
CiteScore
5.70
自引率
5.70%
发文量
40
审稿时长
20 days
期刊介绍: The journal aims to be a platform for the publication and dissemination of knowledge in the area of infection and disease causing infection in humans. The journal is quarterly and publishes research, reviews, concise communications, commentary and other articles concerned with infection and disease affecting the health of an individual, organisation or population. The original and important articles in the journal investigate, report or discuss infection prevention and control; clinical, social, epidemiological or public health aspects of infectious disease; policy and planning for the control of infections; zoonoses; and vaccination related to disease in human health. Infection, Disease & Health provides a platform for the publication and dissemination of original knowledge at the nexus of the areas infection, Disease and health in a One Health context. One Health recognizes that the health of people is connected to the health of animals and the environment. One Health encourages and advances the collaborative efforts of multiple disciplines-working locally, nationally, and globally-to achieve the best health for people, animals, and our environment. This approach is fundamental because 6 out of every 10 infectious diseases in humans are zoonotic, or spread from animals. We would be expected to report or discuss infection prevention and control; clinical, social, epidemiological or public health aspects of infectious disease; policy and planning for the control of infections; zoonosis; and vaccination related to disease in human health. The Journal seeks to bring together knowledge from all specialties involved in infection research and clinical practice, and present the best work in this ever-changing field. The audience of the journal includes researchers, clinicians, health workers and public policy professionals concerned with infection, disease and health.
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