Proximal Humerus Site for Anesthesia
- Conditions
- Intraosseous Vascular Access
- Interventions
- Procedure: proximal humerus intraosseous vascular accessDevice: EZ-IO
- Registration Number
- NCT01866514
- Lead Sponsor
- Vidacare Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Anesthesia Arm proximal humerus intraosseous vascular access proximal humerus intraosseous vascular access will be established bilaterally in the proximal humerus using the anesthesia approach in which the arm is abducted from the body. Anesthesia Arm EZ-IO proximal humerus intraosseous vascular access will be established bilaterally in the proximal humerus using the anesthesia approach in which the arm is abducted from the body. Anesthesia Arm 2% preservative-free lidocaine proximal humerus intraosseous vascular access will be established bilaterally in the proximal humerus using the anesthesia approach in which the arm is abducted from the body.
- Primary Outcome Measures
Name Time Method Intraosseous Infusion Flow rate 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.
- Secondary Outcome Measures
Name Time Method Evaluate relationship between IO and peripheral venous blood Day 1 after establishing proximal humerus IO vascular access and peripheral venous access The secondary objectives for this study are to evaluate the relationship between IO and peripheral venous blood when used for routine laboratory testing.
Secondary Endpoints will include results of routine blood analysis.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 The secondary objectives for this study is to evaluate the infusion pathway from the proximal humerus.
Secondary Endpoint will be time in seconds for fluid delivery from the proximal humerus to the heart, using visualization of contrast injection under fluoroscopy.
Trial Locations
- Locations (1)
Bulverde-Spring Branch EMS
🇺🇸Spring Branch, Texas, United States