Intraosseous Vascular Access
Conditions
Keywords
EZ-IO, IO, Intraosseous Vascular Access
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.
Interventions
DEVICEintraosseous vascular access in the proximal humerus
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.
DEVICEEZ-IO
Sponsors
Vidacare Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraosseous Infusion Flow Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens | 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 Measured in Seconds for Fluid Delivery From the Proximal Humerus Intraosseous (IO) Site to the Heart | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLarry J Miller, MD
Vidacare Corporation
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Region of Enrollment United States | 5 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
None listed