ImportancePeripheral intravenous catheters (PIVCs) facilitate essential treatment. Failure of these essential devices is frequent and new securement strategies may reduce failure and improve patient outcomes.ObjectiveTo evaluate clinical effectiveness of novel PIVC securement technologies for children to reduce catheter failure.Design, Setting, and ParticipantsA 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.InterventionsParticipants 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 MeasuresPrimary 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.ResultsA 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 RelevanceIn 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 RegistrationAustralian New Zealand Clinical Trials Registry Identifier: ACTRN12619001026112

中文翻译：

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新型儿童外周静脉导管固定装置和减少导管故障

重要性外周静脉导管 (PIVC) 有助于基本治疗。这些基本装置经常发生故障，新的固定策略可以减少故障并改善患者的治疗效果。目的评估新型 PIVC 固定技术对儿童减少导管故障的临床有效性。设计、设置和参与者A 3 臂、平行组、随机优势临床试验于 2020 年 2 月 5 日至 2022 年 1 月 14 日在澳大利亚两家地区医院进行。预计需要 PIVC 入院至少 24 小时住院治疗的 6 个月至 8 岁儿童符合资格。数据分析时间为 2022 年 5 月 25 日至 2024 年 2 月 20 日。干预措施参与者以 1:1:1 的比例随机分配至标准护理、镶边聚氨酯 (Tegaderm [3M])、集成固定敷料 (SorbaView SHIELD [Medline]) ，以及带有组织粘合剂的集成固定敷料（Secureport IV）。每名患者研究一根导管。主要结果和措施主要结果是 PIVC 失败，定义为在完成计划治疗之前因任何原因 PIVC 功能过早停止。次要结局是 PIVC 并发症（任何时间的移位、闭塞、浸润、部分移位、外渗、装置渗漏、静脉炎、疼痛）、PIVC 寿命、干预可接受性（临床医生、参与者、护理人员；0-10 等级）以及移除时的疼痛（参与者和护理人员；与年龄相关的 0-10 级）、不良事件和医疗保健费用。结果 总共 383 名患者（51% 为女性；中位年龄 36 [第 25-75 个百分位数，22-72] 个月）被随机分为 134 组标准护理，118 为集成固定敷料，131 为带有组织粘合剂的集成固定敷料。与集成固定敷料 (24 [21%]；aHR，0.78) 相比，使用组织粘合剂的集成固定敷料 (15 [12%]；调整后风险比 [aHR]，0.47；95% CI，0.26-0.84) 的 PIVC 失败率最低；95% CI，0.47-1.28）和标准护理（43 [34%]）。带组织粘合剂的集成固定敷料（中位数，澳元 [A$]，312 [A$1 等于 0.65 美元]；IQR，302-A$380）和集成固定敷料（中位数，A$）的直接成本显着降低与标准护理（中位数为 341 澳元；IQR 为 297 澳元至 592 澳元；磷≤ .002) 在考虑与设备故障相关的经济负担时。所有组的 PIVC 寿命和干预可接受性相似。结论和相关性在这项研究中，与标准护理、镶边聚氨酯敷料相比，使用集成固定敷料和组织粘合剂固定的 PIVC 与入院儿童的 PIVC 失败显着减少相关通过急诊室。进一步的研究应侧重于最需要长时间停留和可靠静脉通路的住院病房的实施。试验注册澳大利亚新西兰临床试验注册标识符：ACTRN12619001026112