A Study to Determine the Safety of Continuous Intraosseous Vascular Access Over a Period of 48 Hours
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Serious Complications From Intraosseous (IO) Access
研究概览
简要总结
A prospective study to determine the safety of intraosseous (IO) access for a period up to 48 hours in healthy adult volunteers and volunteers with a history of mild to moderate renal disease and/or controlled diabetes.
详细描述
A prospective, study to determine the safety of intraosseous (IO) access for a period up to 48 hours, in healthy adult volunteers and volunteers with a history of being health-compromised, including patients with mild to moderate renal disease (National Health and Nutrition Examination Survey Stage 1 to 3) and/or patients with controlled diabetes. Subjects will be randomized to receive IO access in the proximal tibia insertion site or the proximal humerus insertion site using the EZ-IO intraosseous vascular access system. The hypothesis is that there will be no serious complications for the subjects during a 48 hour IO catheter dwell time in either place.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21 years or older
- •Self Identifying as having poor vascular access
- •Healthy or Having at least one of the following conditions:
- •Controlled diabetes, as evidenced by a glycosylated hemoglobin A1c (HbA1c) value of less than or equal to 8% at the time of screening. or
- •Renal disease, Stages 1 to 3, as evidenced by the presence of albuminuria at the time of screening. Subjects albumin-creatinine ratio (ACR) must fall within the microalbuminuria or macroalbuminuria values: Microalbuminuria - ACR 17-250 mcg/mg for men; 25-355 mcg/mg for women or, Macroalbuminuria- ACR >250 mcg/mg for men; >355 mcg/mg for women
排除标准
- •Imprisoned
- •Self identifying as pregnant
- •Cognitively impaired
- •Fracture in target bone
- •Excessive tissue and/or absence of adequated anatomical landmarks in target bone
- •Signs and symptoms of infection in target area
- •IO insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone
- •Intravenous infusion within the past 30 days
- •Current use of anti-coagulants
- •Previous adverse reaction or known allergy to Lidocaine
- •Current cardiac condition requiring pacemaker
- •Currently taking beta blockers or calcium channel blockers for heart arrhythmia (use of beta blockers or calcium channel blocker for hypertension is allowed when indication of hypertension can be confirmed by physician
- •Previous surgery for peripheral arterial disease
- •History of ulcers to the extremities
- •History of bilateral lymph node dissection in the arms or legs
- •Known sickle-cell disease
- •signs or symptoms of vascular disease or vascular insufficiencies to the extremities, as identified upon physical examination
- •History of peripheral vascular disease
- •Hyperkalemia as evidenced by potassium level greater than 5.1 mmol/L the upper limit of hte normal reference range at screening
结局指标
主要结局
Serious Complications From Intraosseous (IO) Access
时间窗: 48 hours
Presence of serious complications from 48 hour intraosseous (IO) vascular access using EZ-IO.
次要结局
未报告次要终点