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Proximal Humerus Site for Anesthesia

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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

Tracking Information
First Submitted Date  ICMJE May 28, 2013
First Posted Date  ICMJE May 31, 2013
Last Update Posted Date June 6, 2014
Study Start Date  ICMJE May 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proximal Humerus Site for Anesthesia
Official Title  ICMJE A Study Evaluating Use of the Proximal Humerus Intraosseous Vascular Access Site for Anesthesia Patient Positioning
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Intraosseous Vascular Access
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Procedure: proximal humerus intraosseous vascular access
  • Drug: 2% preservative-free lidocaine
  • Device: EZ-IO
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2013)
5
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01866514
Other Study ID Numbers  ICMJE 2013-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vidacare Corporation
Study Sponsor  ICMJE Vidacare Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Larry J Miller, MD Vidacare Corporation
PRS Account Vidacare Corporation
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP