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This study is being done to evaluate intraosseous vascular access through the sternum.
The purpose of this study is to evaluate the presence or absence of extravasation when using the T.A.L.O.N. Intraosseous System to establish sternal intraosseous infusion. This study will also evaluate the user preference feedback received from the device operators about the ease of use and level of satisfaction with the device. Lastly, this study will evaluate the infusion flow rates obtained when using intraosseous infusion in the sternum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sternal intraosseous vascular access | Experimental | Sternal intraosseous vascular access using T.A.L.O.N. Intraosseous System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T.A.L.O.N. Intraosseous System | Device | intraosseous catheter for use in the sternum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrences of Extravasation During Infusion | The number of participants with occurrence of extravasation during intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging. | during 12 minutes of infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Stability of Locator | Operator's perceived stability of the sternal locator once placed on the subject. 1 to 5 scale was used with 1=Poor; 2=Fair; 3=Good; 4=Very good; 5=Excellent. | During insertion of the intraosseous needle set |
| Stability of Catheter Hub |
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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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Healthy adults aged 21 years and older were recruited to participate in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sternal Intraosseous Vascular Access | sternal intraosseous vascular access using T.A.L.O.N. T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sternal Intraosseous Vascular Access | sternal intraosseous vascular access using T.A.L.O.N. Sternal Manual Intraosseous Needle set T.A.L.O.N. Sternal Manual Intraosseous Needle set : intraosseous catheter for use in the sternum |
| 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 | Occurrences of Extravasation During Infusion | The number of participants with occurrence of extravasation during intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging. | Posted | Number | participants | during 12 minutes of infusion |
|
|
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participants were monitored during study participation including a telephone follow-up call performed one day after the study procedure to assess for participant reported adverse events.
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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 | Sternal Intraosseous Vascular Access | sternal intraosseous vascular access using T.A.L.O.N. Sternal Manual Intraosseous Needle set T.A.L.O.N. Sternal Manual Intraosseous Needle set : intraosseous catheter for use in the sternum |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larry J. Miller, MD | Vidacare Corporation | 210-375-8500 | larry.miller@vidacare.com |
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Ability to stabilize the catheter hub and rotate the stylet for removal. 1 to 5 scale was used with 1=Very difficult; 2-Difficult; 3=Neutral; 4=Easy; 5=Very easy. |
| During insertion of the intraosseous needle set |
| Adhesion Strips | Perceived effectiveness of the device adhesion strips after application. A 1- 5 scale was used with 1=Poor; 2=Fair; 3=Good; 4=Very good; 5=Excellent. | During insertion of the intraosseous needle set |
| Gravity Flow Rates | Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a gravity infusion (no Pressure). | during the 12 minute infusion time frame |
| 100 Millimeters of Mercury (mmHg) Infusion Flow Rates | Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 100 mmHg infusion. | during the 12 minute infusion time frame |
| 200 Millimeters of Mercury (mmHg) Infusion Flow Rates | Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 200 mmHg infusion. | during the 12 minute infusion time frame |
| 300 Millimeters of Mercury (mmHg) Infusion Flow Rates | Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 300 mmHg infusion. | during the 12 minute infusion time frame |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Stability of Locator | Operator's perceived stability of the sternal locator once placed on the subject. 1 to 5 scale was used with 1=Poor; 2=Fair; 3=Good; 4=Very good; 5=Excellent. | This outcome measure was not reported for one participant, thus only 23 participants were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | Likert scale | During insertion of the intraosseous needle set |
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| Secondary | Stability of Catheter Hub | Ability to stabilize the catheter hub and rotate the stylet for removal. 1 to 5 scale was used with 1=Very difficult; 2-Difficult; 3=Neutral; 4=Easy; 5=Very easy. | Posted | Mean | Standard Deviation | Likert scale | During insertion of the intraosseous needle set |
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| Secondary | Adhesion Strips | Perceived effectiveness of the device adhesion strips after application. A 1- 5 scale was used with 1=Poor; 2=Fair; 3=Good; 4=Very good; 5=Excellent. | Posted | Mean | Standard Deviation | Likert scale | During insertion of the intraosseous needle set |
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| Secondary | Gravity Flow Rates | Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a gravity infusion (no Pressure). | One participant experienced a prior extravasation and therefore did not receive the gravity flowrate infusion. Only 23 participants were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | milliliters per hour | during the 12 minute infusion time frame |
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| Secondary | 100 Millimeters of Mercury (mmHg) Infusion Flow Rates | Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 100 mmHg infusion. | One participant experienced a prior extravasation and therefore did not receive the 100 mmHG flowrate infusion. Only 23 participants were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | milliliters per hour | during the 12 minute infusion time frame |
|
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| Secondary | 200 Millimeters of Mercury (mmHg) Infusion Flow Rates | Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 200 mmHg infusion. | Two participants experienced a prior extravasation and therefore did not receive the 200 mmHg flowrate infusion. For one participant the 200 mmHg flowrate infusion was not performed. Therefore only 21 participants were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | milliliters per hour | during the 12 minute infusion time frame |
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|
|
| Secondary | 300 Millimeters of Mercury (mmHg) Infusion Flow Rates | Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 300 mmHg infusion. | Two subjects experienced a prior extravasation and therefore did not receive the 300 mmHg flowrate infusion. Thus only 22 subjects were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | milliliters per hour | during the 12 minute infusion time frame |
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| 0 |
| 24 |
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| 24 |
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| 24 |
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