Clinical Trials Directory

Trials / Completed

CompletedNCT01866514

Proximal Humerus Site for Anesthesia

A Study Evaluating Use of the Proximal Humerus Intraosseous Vascular Access Site for Anesthesia Patient Positioning

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
5 (actual)
Sponsor
Vidacare Corporation · Industry
Sex
All
Age
21 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEintraosseous vascular access in the proximal humerusThe 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.
DEVICEEZ-IO

Timeline

Start date
2013-05-01
Primary completion
2013-05-01
Completion
2013-06-01
First posted
2013-05-31
Last updated
2026-04-17
Results posted
2026-04-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01866514. Inclusion in this directory is not an endorsement.