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临床试验/NCT03908879
NCT03908879已完成不适用

Prospective Diagnostic Accuracy Study Comparing Sensitivity and Specificity of Methods Used to Confirm Correct Placement of an Intraosseous (IO) Catheter

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年7月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Categorical determination of correct IO catheter placement by blinded reviewers

研究概览

简要总结

This is a prospective diagnostic accuracy study investigating the sensitivity and specificity of methods used to confirm correct placement of an intraosseous (IO) catheter. Intraosseous catheters allow medical providers to rapidly administer fluids and medications to critically ill patients when intravenous (IV) access is not present or difficult to achieve. It is standard of care to confirm the correct placement of an IO catheter prior to using it to administer medications or fluids. Three IO placement confirmatory tests will be performed on all research subjects using a standardized protocol. There will be two index tests (the method utilized by most of the medical community evaluating the stability of the catheter, ability to aspirate blood or bone marrow and ability to administer fluids without visible or palpable extravasation as well as the method of demonstrating color flow Doppler only within the intraosseous space during bedside ultrasound exam) and one reference test (ability to visualized a pulsatile waveform when the IO catheter is attached to a pressure transducer). Primary outcome measures of the study will be the determination of correct or incorrect IO catheter placement from the confirmation methods. This data will be used to investigate the primary endpoints of sensitivity and specificity of the confirmation tests as well as inter-operator variability interpreting the raw data from the confirmation methods. Secondary outcomes include complications from the IO catheter. The goal of this study is to see if a more sensitive and specific method of IO catheter confirmation can reliably be performed by different physicians and reduce the amount of complications associated with the catheters. Additional subgroup analyses will be performed in regards to the research subjects BMI and the anatomic site selected for IO catheter use (proximal tibia or humeral head).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

There is only one arm because all participants will be undergoing the same protocol. To evaluate inter-operator variability for methods 2 and 3, co-investigators will be reviewing saved images recorded by the physicians who placed the intraosseous (IO) catheter. Saved images include the color flow Doppler image for method 2 and the pressure waveform for method 3. Two co-investigators will review saved images from method 2, blinded and independently. Two other co-investigators will review saved images from method 3, blinded and independently. If the results of the two co-investigators for method 2 or method 3 is discordant then a third blinded reviewer will review the saved image for the method with discordant results.

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 greater than 18 years of age
  • Full code
  • Require placement of an intraosseous catheter for emergent resuscitation due to lack of reliable intravenous access
  • Capable of undergoing all three intraosseous placement confirmatory methods

排除标准

  • Age less than 18 years old
  • Pregnant patients
  • Prisoner/incarcerated
  • Patients unable to undergo all three intraosseous placement confirmatory methods

结局指标

主要结局

Categorical determination of correct IO catheter placement by blinded reviewers

时间窗: Within 1 week of ultrasound images and pressure transduction images being created by the physician placing the IO catheter

Categorical determination (yes/no) regarding correct IO catheter placement in the intraosseous space for method 2 and method 3 by the blinded reviewers

Categorical determination of correct IO catheter placement by physicians placing the catheter

时间窗: Within 24 hours of intraosseous (IO) catheter insertion

Categorical determination (yes/no) regarding correct IO catheter placement in the intraosseous space of all three confirmatory methods from the physicians placing the IO catheter

次要结局

  • IO catheter pressure(Within 24 hours of intraosseous (IO) catheter insertion)
  • Systemic blood pressure(Within 24 hours of intraosseous (IO) catheter insertion)
  • Number of attempts to place IO catheter(Within 24 hours of intraosseous (IO) catheter insertion)
  • Complications related to IO catheter(Within 28 days of IO catheter insertion)

研究者

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

Yonatan Greenstein, MD

Associate Professor of Medicine, Division of Pulmonary & Critical Care Medicine

Rutgers, The State University of New Jersey

研究点 (2)

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