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临床试验/CTRI/2025/07/090321
CTRI/2025/07/090321尚未招募4 期

Functional Durability of Peripheral Intravenous Cannula with Attached Three-way Stopcock Without Extension Tubing and With 10 cm Extension Tubing in Children – A Randomized Control Trial

VEMULA ABHINAY1 个研究点 分布在 1 个国家目标入组 640 人开始时间: 2025年8月3日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
640
试验地点
1
主要终点
Functional durability of the PIVCs in each age group

研究概览

简要总结

Peripheral intravenous catheter (PIVC) insertion is a common invasive procedure performed in up to 80 percent of hospitalized patients for the administration of fluids, medications, and blood products. Despite their utility, PIVCs have a high failure rate ranging from 35 to 50 percent, influenced by various factors including chemical (irritant drugs), mechanical (catheter size, material, location, and insertion technique), infection-related (skin flora migration or contaminated hub), and patient-specific factors (age, existing infections). Complications such as thrombophlebitis, extravasation, and occlusion contribute significantly to PIVC failure. Frequent PIVC changes depletes health care resources and gives additional risk. To improve functionality and reduce risks, 3-way stopcocks and various extension sets are used to deliver multiple infusions through a single site. Extension tubing enhances access, reduces contamination, and supports patient comfort, although it may pose risks like residual drugs and dislodgement. By maintaining a closed system and minimizing line manipulation, extensions potentially decrease complications and resource use. But till now, very limited number of studies are available that compare the functional durability (Dwell time) of different types of iv extensions. This research will compare the Durability of two types of three-way stopcocks, i.e., stopcock without any 10 cm extension tubing and that with a 10 cm extension tubing. The research data from this study will serve as critical knowledge that healthcare providers can use to create better IV therapy guidelines and improve patient care quality.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Month(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Children aged 1month to 14 years requiring PIVC for more than 24 hours.

排除标准

  • Pre-existing thrombophlebitis, infection or burn at local site Patients with coagulopathy or on anticoagulants If PIVC is needed for less than 24 hours.

结局指标

主要结局

Functional durability of the PIVCs in each age group

时间窗: 18 months

次要结局

  • The incidence rates of thrombophlebitis & its grading(•Incidence of other complications like occlusion, extravasation & local infection)

研究者

发起方
VEMULA ABHINAY
申办方类型
Other [Principle investigator]
责任方
Principal Investigator
主要研究者

VEMULA ABHINAY

AIIMS MANGALAGIRI, central institute

研究点 (1)

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