Clinical trial NCT01866514: Proximal Humerus Site for Anesthesia
Official title: A Study Evaluating Use of the Proximal Humerus Intraosseous Vascular Access Site for Anesthesia Patient Positioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraosseous Vascular Access
Keywords: EZ-IO
IO
Intraosseous Vascular Access
Lead sponsor: Vidacare Corporation
Sponsor class: INDUSTRY
First posted: 2013-05-31
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Have an active infection in the body Imprisoned Pregnant 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

Primary outcomes:
measure: Intraosseous Infusion Flow rate
timeFrame: Day 1 after establishing proximal humerus IO vascular access
Secondary outcomes:
measure: Evaluate relationship between IO and peripheral venous blood
timeFrame: Day 1 after establishing proximal humerus IO vascular access and peripheral venous access
measure: The secondary objective for this study is to evaluate the infusion pathway from the proximal humerus to the heart.
timeFrame: Day 1 after establishing proximal humerus intraosseous vascular access
Other outcomes:
Locations:
city: Spring Branch
country: United States
facility: Bulverde-Spring Branch EMS
state: Texas
Study officials:
affiliation: Vidacare Corporation
name: Larry J Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: