跳至主要内容
临床试验/NCT06217783
NCT06217783招募中不适用

Ultrasound-guided Peripheral Intravenous Catheter Placement in an Oncologic Emergency Department - a Prospective, Randomized Controlled Trial of Catheter Lengths

M.D. Anderson Cancer Center2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年3月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
2
主要终点
Safety and adverse events (AEs)

研究概览

简要总结

To learn about the effects of the length of the catheter on the failure and success rate of USIV placement.

详细描述

Primary Objectives:

- The rate of catheter failure, defined as removal of the catheter for any reason other than "Care Complete" (i.e. a composite of removal due to "infiltration," "leaking," "catheter damage," "occlusion"), by day 10.

Secondary Objectives:

  1. Time from catheter placement to removal (i.e. survival or dwell time).
  2. Per catheter length rate of failure analysis
  3. Rate of repeat catheterization
  4. Rate of infection
  5. Rate of thrombosis

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years old.
  • Provision of signed and dated informed consent form.
  • Predetermined to have difficult IV access necessitating USIV placement
  • Expected admission to hospital with anticipated stay > 48 hours (per discussion with treating physician).

排除标准

  • Expected/anticipated discharge disposition from the ACCC (per discussion with treating physician).
  • Inability to give informed consent.
  • Pregnant women.
  • Non-English speaking participants.

研究组 & 干预措施

Group A

Experimental

Participants will receive a catheter that is up to 1.75 inches long based on what the nurse thinks is best for you.

干预措施: Introcan Safety IV Catheter (Device)

Group B

Experimental

Participants will receive a catheter that is either 1.75 or 2.5 inches long based on what the nurse thinks is best for you.

干预措施: Introcan Safety IV Catheter (Device)

结局指标

主要结局

Safety and adverse events (AEs)

时间窗: Through study completion; an average of 1 year.

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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