A Study Evaluating Use of the Proximal Humerus Intraosseous Vascular Access Site for Anesthesia Patient Positioning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Intraosseous Infusion Flow rate
研究概览
简要总结
This will be a prospective, non-controlled study using healthy adult volunteers as subjects receiving bilateral proximal humerus intraosseous (IO) vascular access to evaluate the insertion technique and IO infusion flow rates.
详细描述
When using IO access in the perioperative and OR settings, abduction of the arms to the shoulder level prevents use of the traditional proximal humerus insertion site due to the rotation of the humeral head under the acromion process. An alternate proximal humerus IO insertion technique has been developed to meet the needs of anesthesia patient positioning that uses a slightly more distal insertion site and a superior angle of insertion. However infusion flow rate in the proximal humerus using the anesthesia technique has not been measured. This study is needed to evaluate the anesthesia proximal humerus IO insertion technique to determine if the IO infusion flow rates remain unchanged by the alternate method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 21 years or older
- •Have no amputation of the upper extremities
- •Able to lay flat on table for up to 2 hours
- •Self-reported as healthy, as confirmed by the PI
排除标准
- •Have an active infection in the body
- •Imprisoned
- •Cognitively impaired
- •Fracture in humerus, or significant trauma to the site
- •Excessive tissue and/or absence of adequate anatomical landmarks in humerus
- •Infection in target area
- •Humeral IO insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in humerus
- •Current use of anti-coagulants
- •Current cardiac condition requiring pacemaker or anti-arrhythmic drugs
- •Prior adverse reaction to lidocaine
- •Volunteers with any of the following characteristics may be excluded from the infusion pathway evaluation involving administration of contrast dye at the discretion of the PI:
- •Prior adverse reaction to contrast dye
- •Allergy to any food or drug
- •History of impaired renal function
- •History of impaired hepatic function
- •History of cardiac disease
- •History of pheochromocytoma
研究组 & 干预措施
Proximal Humerus Intraosseous Vascular Access - Anesthesia Position
Adult healthy volunteers receiving bilateral proximal humerus intraosseous vascular access while arm is positioned abducted from the body at shoulder level, bilaterally. This arm position is referred to as the "anesthesia position"
干预措施: intraosseous vascular access in the proximal humerus (Device)
Proximal Humerus Intraosseous Vascular Access - Anesthesia Position
Adult healthy volunteers receiving bilateral proximal humerus intraosseous vascular access while arm is positioned abducted from the body at shoulder level, bilaterally. This arm position is referred to as the "anesthesia position"
干预措施: EZ-IO (Device)
结局指标
主要结局
Intraosseous Infusion Flow rate
时间窗: Day 1 after establishing proximal humerus IO vascular access
The primary objective of the study is to evaluate the infusion flow rates attainable when using the anesthesia approach to establish proximal humerus IO vascular access. The primary endpoints will be the infusion flow rate obtained at each tested infusion pressure, including gravity, 100 mmHg, 200 mmHg, and 300 mmHg.
Intraosseous Infusion Flow Rate
时间窗: Day 1, within 30 minutes of establishing proximal humerus intraosseous (IO) vascular access
the mean infusion flow rate reported in milliliters per hour (mL/hr) obtained at each tested infusion pressure.
次要结局
- Evaluate relationship between IO and peripheral venous blood(Day 1 after establishing proximal humerus IO vascular access and peripheral venous access)
- The secondary objective for this study is to evaluate the infusion pathway from the proximal humerus to the heart.(Day 1 after establishing proximal humerus intraosseous vascular access)
- Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens(Day 1 within 30 minutes after establishing proximal humerus IO vascular access and peripheral venous access)
- Time Measured in Seconds for Fluid Delivery From the Proximal Humerus Intraosseous (IO) Site to the Heart(Day 1 within 1 hour after establishing proximal humerus intraosseous vascular access)