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Slow rate of enrollment
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An observational study to determine the safety and effectiveness of Intraosseous (IO) vascular access for delivery of contrast dye for Computed Tomography (CT) examination. The hypothesis is that IO access can be safely and effectively used to deliver contrast medium for CT examination.
An observational study to determine the safety and effectiveness of Proximal Humerus Intraosseous (IO) vascular access for delivery of contrast medium for Computed Tomography (CT) examination. The hypothesis is that Proximal Humerus IO access in conjunction with a pressure-limited power injection device can be safely and effectively used to deliver contrast medium for CT examination.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraosseous delivery of CT contrast dye | Procedure | Delivery of CT contrast through intraosseous vascular access at the proximal humerus for CT examination. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adequacy of Computed Tomography (CT) Image | Adequacy of CT image graded as adequate or inadequate indicating the ability to effectively administer the contrast medium needed for the indicated CT examination. | at time of CT examination average time is within 24 hours |
| Incidence of Complication With Administration of Contrast for Computed Tomography (CT) Examination | incidence of complications associated with the administration of contrast through the proximal humerus intraosseous (IO) route for CT examination | at time of CT examination average time is within 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients who have received proximal humerus intraosseous vascular access as standard of care via the EZ-IO 45 mm needle set and require Computed Tomography (CT) examination
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Philbeck, PhD | Sponsor Company- Vidacare Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maricopa Medical Center | Phoenix | Arizona | 85008 | United States | ||
| Olive View UCLA Medical Center |
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observational study with patients enrolled in the emergency department
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| ID | Title | Description |
|---|---|---|
| FG000 | Proximal Humerus Intraosseous (IO) Computed Tomography (CT) Contrast | Adult patients in the emergency department receiving administration of contrast, via intraosseous (IO) vascular access established in the proximal humerus, for the purpose of computed tomography (CT) examination. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sylmar |
| California |
| 91342 |
| United States |
| Shands Critical Care Center and Cancer Hospital | Gainesville | Florida | 32608 | United States |
| Grand Strand Regional Medical | Myrtle Beach | South Carolina | 29572 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Proximal Humerus Intraosseous (IO) Computed Tomography (CT) Contrast | Adult patients in the emergency department receiving administration of contrast, via intraosseous (IO) vascular access established in the proximal humerus, for the purpose of computed tomography (CT) examination. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Adequacy of Computed Tomography (CT) Image | Adequacy of CT image graded as adequate or inadequate indicating the ability to effectively administer the contrast medium needed for the indicated CT examination. | Posted | Count of Participants | Participants | at time of CT examination average time is within 24 hours |
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| Primary | Incidence of Complication With Administration of Contrast for Computed Tomography (CT) Examination | incidence of complications associated with the administration of contrast through the proximal humerus intraosseous (IO) route for CT examination | Posted | Number | complications | at time of CT examination average time is within 30 minutes |
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During the time of contrast administration until the end of follow up, up to 30 days
patients were contacted 30 days following the contrast administration and asked if they experienced any adverse events. Per protocol, only other adverse events (not including serious adverse events) determined by the principal investigator (PI) to have at least a possible relationship to the contrast administration via the proximal humerus intraosseous vascular access route were recorded for this observational study by the PI.
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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 (IO) Computed Tomography (CT) Contrast | Adult patients in the emergency department receiving administration of contrast, via intraosseous (IO) vascular access established in the proximal humerus, for the purpose of computed tomography (CT) examination. | 0 | 8 | 0 | 8 | 0 | 8 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tatiana Puga | Teleflex | tatiana.puga@teleflex.com |
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