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临床试验/NCT01742780
NCT01742780已完成不适用

A Study Evaluating Insertion Site Identification Methods Used to Establish Intraosseous Vascular Access in the Proximal Humerus

Vidacare Corporation2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Ease of use score

研究概览

简要总结

The purpose of this study is to determine if there is one method of identifying the proximal humerus intraosseous vascular access site that is easier for clinicians to use, out of the 4 methods being evaluated.

详细描述

This was a non-controlled study using licensed/certified EMT/paramedics and licensed nurses as device operator subjects identifying the proximal humerus IO insertion site and inserting the IO catheter in healthy adult volunteers. Forty (40) clinicians with no prior training on establishing IO vascular access in the proximal humerus IO insertion site were enrolled in the study as device operator subjects. Twenty (20) healthy adult volunteers were enrolled in the study to have IO vascular access established bilaterally in the proximal humerus with one device operator accessing one of the subject's arms, according to their assigned method for identifying the proximal humerus intraosseous vascular access site.

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

入选标准

  • Device Operators:
  • Recent/current experience in the medical field as a practicing clinician.
  • Currently licensed/certified Emergency Medicine Technician, paramedic, or nurse
  • Have had no formal training on use of the proximal humerus intraosseous insertion site.

排除标准

  • Device Operators:
  • There is no exclusion criteria
  • Inclusion Criteria Healthy Volunteers
  • Age 21 years or older.
  • Has no amputation of the upper extremities.
  • Able to lay flat on table for up to 2 hours.
  • Self-reported as healthy.
  • Exclusion Criteria Healthy Volunteers:
  • 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 intraosseous insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in humerus
  • Current use of anti-coagulants

研究组 & 干预措施

Vidacare Method for Intraosseous Insertion

Other

Clinicians with no prior training on identifying the proximal humerus IO insertion site to be trained on the Standard Vidacare Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Standard Vidacare Method description is: Palpate up the proximal humerus towards the anterior shoulder just above the surgical neck, to the greater tubercle of the proximal humerus. Insert the needle set perpendicular to skin with a slight downward angle at the most prominent aspect of greater tubercle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access.

干预措施: Intraosseous Vascular Access (Other)

Saussy Method for Intraosseous Insertion

Other

Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Saussy Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Saussy Method description is: Palpate the proximal humerus to locate the intertubercular groove; rotate the forearm medially and laterally to isolate the groove. Move one finger breadth laterally from the groove to the greater tubercle. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access

干预措施: Intraosseous Vascular Access (Other)

Davlantes Method for Intraosseous Insertion

Other

Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Davlantes Method site identification method and perform one unilateral proximal humerus IO needle insertion. The description of the Davlantes Method is: Using one hand, place the thumb on the acromioclavicular joint in the natural recess or "pocket" between the distal clavicle and the humeral head, wrapping the rest of the hand around the upper arm. The hand should be oriented such that the index finger and rest of the hand is at a 90-degree angle to the thumb. The webspace between the thumb and index finger will be approximately where the surgical neck of the humerus is; move one finger breadth (approximately 1 cm) superior. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access

干预措施: Intraosseous Vascular Access (Other)

Campbell Method for Intraosseous Insertion

Other

Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Campbell Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Campbell Method description is: With the fingers on both hands fully extended similar to a karate chop, place one hand into the anterior joint space (acromioclavicular joint) of the patient. Place the second "karate chop" hand along the midline of the patient's lateral shoulder; touch the pinkie fingers over the superior aspect of the patient's shoulder. Overlap the thumbs on the patient's shoulder, which will be at the most prominent aspect of the greater tubercle. Insert the needle set perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access

干预措施: Intraosseous Vascular Access (Other)

Healthy Subjects: Campbell and Saussy Methods

Other

Healthy Subjects received bilateral intraosseous (IO) vascular access in the proximal humerus by device operators using the Saussy Method on one proximal humerus and the Campbell method on the other proximal humerus.

干预措施: Intraosseous Vascular Access (Other)

Healthy Subject: Davlantes and Standard Vidacare Methods

Other

Subjects received bilateral intraosseous (IO) vascular access in the proximal humerus by device operators using the Davlantes Method on one proximal humerus and the Standard Vidacare method on the other proximal humerus.

干预措施: Intraosseous Vascular Access (Other)

结局指标

主要结局

Ease of use score

时间窗: Within 10 minutes of procedure

Device operators will complete an ease of use questionnaire regarding the assigned site identification method.

Level of confidence score

时间窗: within 10 minutes of procedure

Device operators will complete a level of confidence questionnaire regarding their assigned site identification method.

Site identification success/failure

时间窗: within 10 minutes of the procedure

The ability of the device operator to identify the proximal humerus intraosseous insertion site will be graded as success or failure.

Time to intraosseous catheter placement

时间窗: within 10 minutes of the procedure

The amount of time it takes for the device operator to identify the proximal humerus intraosseous insertion site and insert the needle.

Ease of Use Score

时间窗: Within 10 minutes of procedure

Device operators will score their perceived Ease of Use for their assigned Intraosseous Insertion method for their one unilateral proximal humerus IO site procedure. The Ease of Use scale scores range from 0 to 10, where 0=extremely difficult and 10=extremely easy. Higher scores indicate greater ease of use.

Level of Confidence Score

时间窗: within 10 minutes of procedure

Device operators scored their perceived Level of Confidence with their assigned Intraosseous Insertion method for their one unilateral proximal humerus IO site procedure. The Level of Confidence scale scores range from 0 to 10, where. 0=no confidence and 10=extremely confident. Higher scores indicate greater level of confidence.

Proximal Humerus Intraosseous (IO) Insertion Site Placement Score

时间窗: within 10 minutes of the procedure

The ability of the device operator to insert the Intraosseous device into the "ideal target area" was scored using an accuracy scoring scale. The "ideal target area" was defined as the center of the greater tubercle. The following scoring scale ranging from 0 to 3 was used. 3= center of the greater tubercle; 2=sightly off-center of the greater tubercle, 1=borderline of the greater tubercle, and 0=completely outside the greater tubercle. Higher scores indicate better insertion position.

Time to Intraosseous (IO) Catheter Placement

时间窗: within 10 minutes of the procedure

The amount of time it takes for the device operator to identify the proximal humerus intraosseous (IO) insertion site using their assigned proximal humerus IO site identification method and insert the IO needle Timing starts from the time the participant begins to palpate the proximal humerus and stops when the IO needle is inserted.

次要结局

未报告次要终点

研究者

发起方
Vidacare Corporation
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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