Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
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.

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
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

Arm Intervention/treatment
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.
Other Names:
  • EZ-IO
  • Instraosseous Access
  • Proximal Humerus intraosseous access
  • IO access
  • proximal humerus IO access

Drug: 2% preservative-free lidocaine
Device: EZ-IO



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Texas
Bulverde-Spring Branch EMS
Spring Branch, Texas, United States, 78070
Sponsors and Collaborators
Vidacare Corporation
Investigators
Layout table for investigator information
Principal Investigator: Larry J Miller, MD Vidacare Corporation
Layout table for additonal information
Responsible Party: Vidacare Corporation
ClinicalTrials.gov Identifier: NCT01866514    
Other Study ID Numbers: 2013-07
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: May 2013
Keywords provided by Vidacare Corporation:
EZ-IO
IO
Intraosseous Vascular Access
Additional relevant MeSH terms:
Layout table for MeSH terms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action