Bulverde-Spring Branch EMS
Spring Branch, Texas, 78070, United States
NCT Number: NCT01866514
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.
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Notify Me21 year and older
All sexes
Interventional
Not applicable
Spring Branch, Texas, 78070, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The arm receiving the Intraosseous (IO) needle is positioned with the arm abducted to shoulder level (in position required for surgery), with the arm rotated inward, into the optimal position, with the palms faced down. Deeply palpate the humerus until the junction of the humeral shaft and the humeral head, the surgical neck is identified; the insertion site is in the surgical neck. With the 45mm IO needle placed perpendicular to the plane of the skin, the IO needle is inserted into the surgical neck using a slightly superior angle of insertion and the needle is inserted to the hub. The stylet will be removed and a primed EZ-Connect will be attached to the catheter hub.
Other names: EZ-IO, Proximal Humerus intraosseous access, IO access, proximal humerus IO access
Time frame: 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.
Time frame: Day 1 within 30 minutes after establishing proximal humerus IO vascular access and peripheral venous access
Number of Participants with Laboratory Results Successfully Obtained from both intraosseous (IO) and peripheral venous blood specimens. Success was determined if the point-of-care laboratory analysis system provided laboratory results values for both IO and Peripheral Venous specimens. It was deemed unsuccessful if the point-of-care system provided no laboratory results values and/or noted an error for at least one specimen. An intraosseous blood specimen and a peripheral venous blood specimen were collected from each subject.
Time frame: Day 1 within 1 hour after establishing proximal humerus intraosseous vascular access
time measured in seconds for fluid delivery from the proximal humerus intraosseous site to the heart, using visualization of contrast injection under fluoroscopy.
Vidacare Corporation
Industry
A Study Evaluating Use of the Proximal Humerus Intraosseous Vascular Access Site for Anesthesia Patient Positioning
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