An Observational Study to Determine the Safety and Effectiveness of Intraosseous Vascular Access for the Delivery of CT Contrast Dye
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Adequacy of Computed Tomography (CT) Image
研究概览
简要总结
An observational study to determine the safety and effectiveness of Intraosseous (IO) vascular access for delivery of contrast dye for Computed Tomography (CT) examination. The hypothesis is that IO access can be safely and effectively used to deliver contrast medium for CT examination.
详细描述
An observational study to determine the safety and effectiveness of Proximal Humerus Intraosseous (IO) vascular access for delivery of contrast medium for Computed Tomography (CT) examination. The hypothesis is that Proximal Humerus IO access in conjunction with a pressure-limited power injection device can be safely and effectively used to deliver contrast medium for CT examination.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Has received intraosseous (IO) vascular access at the proximal humerus insertion site via EZ-IO 45 mm needle set, as standard of care
- •Requires Computed Tomography (CT) examination with contrast media delivery via proximal humerus intraosseous catheter, as standard of care
- •Cognitively and physically able to give written consent to participate in the study or is obtained from a Legally Authorized Representative (LAR)
排除标准
- •Fracture in target bone, or significant trauma to the site
- •Excessive tissue and/or absence of adequate anatomical landmarks in target bone
- •Infection in target area
- •IO insertion in past 24 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone
- •Allergy to contrast media
- •Imprisoned
- •Requires English language translation other than Spanish
- •Has received proximal humerus IO access with an IO catheter other than the EZ-IO 45 millimeter (mm) needle set system
- •Has existing proximal humerus IO access using the EZ-IO 45 mm needle set but IO catheter is mal-positioned or dislodged
结局指标
主要结局
Adequacy of Computed Tomography (CT) Image
时间窗: at time of CT examination average time is within 24 hours
Adequacy of CT image graded as adequate or inadequate indicating the ability to effectively administer the contrast medium needed for the indicated CT examination.
Incidence of Complication With Administration of Contrast for Computed Tomography (CT) Examination
时间窗: at time of CT examination average time is within 30 minutes
incidence of complications associated with the administration of contrast through the proximal humerus intraosseous (IO) route for CT examination
次要结局
未报告次要终点