Proximal Humerus Site for Anesthesia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01866514|
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : June 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Intraosseous Vascular Access||Procedure: proximal humerus intraosseous vascular access Drug: 2% preservative-free lidocaine Device: EZ-IO||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study Evaluating Use of the Proximal Humerus Intraosseous Vascular Access Site for Anesthesia Patient Positioning|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: Anesthesia Arm
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.
Procedure: proximal humerus intraosseous vascular access
The arm receiving the 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 an EZ-Connect primed with 2% preservative-free lidocaine will be attached to the catheter hub. Aspirate return will be attempted to confirm needle placement within the medullary cavity.
Drug: 2% preservative-free lidocaine
- Intraosseous Infusion Flow rate [ Time Frame: 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.
- Evaluate relationship between IO and peripheral venous blood [ Time Frame: 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. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866514
|United States, Texas|
|Bulverde-Spring Branch EMS|
|Spring Branch, Texas, United States, 78070|
|Principal Investigator:||Larry J Miller, MD||Vidacare Corporation|