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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proximal Humerus Intraosseous Vascular Access - Anesthesia Position | Experimental | Adult healthy volunteers receiving bilateral proximal humerus intraosseous vascular access while arm is positioned abducted from the body at shoulder level, bilaterally. This arm position is referred to as the "anesthesia position" |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraosseous vascular access in the proximal humerus | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraosseous Infusion Flow Rate | the mean infusion flow rate reported in milliliters per hour (mL/hr) obtained at each tested infusion pressure. | Day 1, within 30 minutes of establishing proximal humerus intraosseous (IO) vascular access |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry J Miller, MD | Vidacare Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bulverde-Spring Branch EMS | Spring Branch | Texas | 78070 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Proximal Humerus Intraosseous Vascular Access - Anesthesia Position | Adult healthy volunteers receiving bilateral proximal humerus intraosseous vascular access while arm is positioned abducted from the body at shoulder level, bilaterally. This arm position is referred to as the "anesthesia position" |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Proximal Humerus Intraosseous Vascular Access - Anesthesia Position | Adult healthy volunteers receiving bilateral proximal humerus intraosseous vascular access while arm is positioned abducted from the body at shoulder level, bilaterally. This arm position is referred to as the "anesthesia position" |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraosseous Infusion Flow Rate | the mean infusion flow rate reported in milliliters per hour (mL/hr) obtained at each tested infusion pressure. | Intraosseous (IO) infusion flow rate evaluation was performed following administration of a syringe flush of 10 milliliters of normal saline, then using the infusion pressure of 300 mmHg only. The Intraosseous infusion flow rate evaluation was not performed for 2 subjects, therefore only 3 subjects are included in analysis. | Posted | Mean | Standard Deviation | mL / hour | Day 1, within 30 minutes of establishing proximal humerus intraosseous (IO) vascular access |
|
24 hours, from enrollment in the study on day 1 through 24 hours follow up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Proximal Humerus Intraosseous Vascular Access - Anesthesia Position | Adult healthy volunteers receiving bilateral proximal humerus intraosseous vascular access while arm is positioned abducted from the body at shoulder level, bilaterally. This arm position is referred to as the "anesthesia position" |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tatiana Puga | Teleflex | tatiana.puga@teleflex.com |
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| EZ-IO | Device |
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| Day 1 within 30 minutes after establishing proximal humerus IO vascular access and peripheral venous access |
| Time Measured in Seconds for Fluid Delivery From the Proximal Humerus Intraosseous (IO) Site to the Heart | time measured in seconds for fluid delivery from the proximal humerus intraosseous site to the heart, using visualization of contrast injection under fluoroscopy. | Day 1 within 1 hour after establishing proximal humerus intraosseous vascular access |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Secondary | Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens | 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. | Posted | Count of Participants | Participants | Day 1 within 30 minutes after establishing proximal humerus IO vascular access and peripheral venous access |
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| Secondary | Time Measured in Seconds for Fluid Delivery From the Proximal Humerus Intraosseous (IO) Site to the Heart | time measured in seconds for fluid delivery from the proximal humerus intraosseous site to the heart, using visualization of contrast injection under fluoroscopy. | contrast injection for infusion pathway evaluation was not performed on 2 subjects; therefore only 3 subjects were included. | Posted | Mean | Standard Deviation | seconds | Day 1 within 1 hour after establishing proximal humerus intraosseous vascular access |
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| 0 |
| 5 |
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| 5 |
| 0 |
| 5 |
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