■外周静脉导管(PIVC)有助于进行必要的治疗。这些基本装置的故障是频繁的,并且新的固定策略可以减少故障并改善患者结果。
■评估儿童新型PIVC固定技术的临床有效性,以减少导管故障。
■3臂,平行组,优势随机临床试验于2020年2月5日至2022年1月14日在澳大利亚2家地区医院进行.6个月至8岁的儿童,预计需要接受PIVC至少24小时的住院治疗,符合资格。数据从2022年5月25日至2024年2月20日进行了分析。
■参与者以1:1:1的比例随机分配给标准护理,镶边聚氨酯(Tegaderm[3M]),集成固定敷料(SorbaViewSHIELD[Medline]),和集成的固定敷料与组织粘合剂(SecureportIV)。每位患者研究一根导管。
■主要结果是PIVC失败,定义为在完成计划治疗之前,由于任何原因而过早停止PIVC功能。次要结果是PIVC并发症(任何时间移位,遮挡,渗透,部分移位,外渗,设备泄漏,静脉炎,疼痛),PIVC长寿,干预可接受性(临床医生,参与者,护理人员;0-10量表),和移除疼痛(参与者和护理人员;与年龄相关的0-10量表),不良事件,和医疗费用。
■共有383名患者(51%为女性;中位年龄36岁[第25-75百分位数,22-72个月)被随机分配134接受标准护理,118至集成固定敷料,和131到具有组织粘合剂的集成固定敷料。在使用组织粘合剂的一体化固定敷料中,PIVC失败最低(15[12%];调整后的危险比[aHR],0.47;95%CI,0.26-0.84)与集成固定敷料(24[21%];AHR,0.78;95%CI,0.47-1.28)和标准护理(43[34%])。使用组织粘合剂的集成固定敷料的直接费用显着降低(中位数,澳元[A$],312[1美元等于0.65美元];IQR,A$302-A$380)和集成固定敷料(中位数,A$303;IQR,A$294-A$465)与标准护理(中位数,341美元;IQR,A$297-A$592;P≤.002)在考虑与设备故障有关的经济负担时。所有组的PIVC寿命和干预可接受性相似。
■在这项研究中,用集成固定敷料和组织粘合剂固定的PIVC,与标准护理相比,有边界的聚氨酯敷料,与显著减少的PIVC失败相关,通过急诊科入院的儿童。进一步的研究应集中在最需要长时间停留和可靠的静脉通路的住院单位中实施。
■澳大利亚新西兰临床试验注册标识符:ACTRN12619001026112。
UNASSIGNED: 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.
UNASSIGNED: To evaluate clinical effectiveness of novel PIVC securement technologies for children to reduce catheter failure.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12619001026112.