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临床试验/NCT02618252
NCT02618252撤回不适用

Preventing Delay of Care in Patient With Difficult IV Access: A Randomized Trial of ED Intervention

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2016年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
216
试验地点
2
主要终点
Operator's time

研究概览

简要总结

Patients with difficulty intravenous access frequently have delay of care in emergency departments because Emergency Department (ED) personnel could not establish intravenous (IV) access for diagnostic blood test or treatment. The ultrasound machine or near-infrared devices have been used to improve this situation but no study has ever compared which machine is more efficient. This study is designed to investigate whether the ultrasound or Vein Viewer, which is a near-infrared device, is more efficient.

详细描述

Intravenous (IV) access is important for patient care in emergency medicine as an estimate of 78% of ED patients would require more than 3 ED resources such as blood tests, medication, contrast, fluid. Care for patients with difficult intravenous access (DIVA) could be significantly delayed as it may take up to 120 minutes to establish IV access in patients with severe DIVA. Many solutions for DIVA had also been established to avoid central venous catheter insertion, including using ultrasound or near-infrared imaging systems for peripheral IV insertion.

Using ultrasound in the ED has been shown to decrease the rate of central venous catheters (CVC) insertion. However, the results from ultrasound-guided peripheral IV insertion (USGPIV) have been mixed. Among patients with DIVA, Costantino reported USGPIV required less time to successful first cannulation and fewer punctures comparing to traditional approach of landmark and palpation. However, other studies showed that USGPIV did not improve successful first attempts comparing to traditional IV insertion, and may have taken same or even longer time to successfully establish IV. USGPIV success rate requires more training for nurses and ED technicians as it is operator - dependent.

Patients have difficulty with IV access because their veins' clinical accessibility is low, for example, they are less visible or less palpable. The near-infrared imaging devices, such as Christie Digital's VeinViewer, improve this situation by using infra-red lights to make veins visible to the eyes.

Compared with routine IV insertion, near-Infra red imaging devices have been shown to increase first successful attempts and in less time in children with DIVA and improved visualization of peripheral veins. However, it did not show higher rate of successful attempts nor faster time in non-selected adults.

The efficacy of these near-infrared devices has not been established among adult patients with DIVA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • Patients who fail inspections for visible or palpable veins or
  • Patients who request Ultrasound guided peripheral IV (USGPIV)
  • patients who are oriented to self (correct last name, first name), place (correct name of hospital), time (correct day of week or month of year) and person (correct name of current president)

排除标准

  • Patients < 18 years of age
  • Patients with hemodynamically instability requiring rapid central access.
  • Patients with impaired cognition and not able to consent, these patients are :
  • Clinically intoxicated patients, as defined by primary team.
  • Patients who family reported as "confused", "confusion", "altered mental status."
  • Patients who is not oriented x 4 as above
  • Patients who do not speak English.

结局指标

主要结局

Operator's time

时间窗: up to 40 minutes

time from equipment-in-room to successful aspiration of 3ml of blood

次要结局

  • Patient satisfaction(up to 40 minutes)
  • Cannulation time(40 minutes)
  • Number of failure to cannulate(40 minutes)
  • Number of first successful attempts(40 minutes)
  • IV size(40 minutes)
  • ED length of stay(24 hours)
  • hospital length of stay for admitted patient(30 days)
  • Number of failures(40 minutes)
  • Patient's perception of pain(up to 40 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Quincy Tran

Assosciate Professor

University of Maryland, Baltimore

研究点 (2)

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