Patients With Intraosseous Vascular Access Requiring Computed Tomography (CT) Exam
Conditions
Keywords
intraosseous vascular access, Computed Tomography (CT) examination
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREIntraosseous delivery of CT contrast dye
Delivery of CT contrast through intraosseous vascular access at the proximal humerus for CT examination.
Sponsors
Vidacare Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Has received intraosseous (IO) vascular access at the proximal humerus insertion site via EZ-IO 45 mm needle set, as standard of care * Requires Computed Tomography (CT) examination with contrast media delivery via proximal humerus intraosseous catheter, as standard of care * Cognitively and physically able to give written consent to participate in the study or is obtained from a Legally Authorized Representative (LAR)
Exclusion criteria
* Fracture in target bone, or significant trauma to the site * Excessive tissue and/or absence of adequate anatomical landmarks in target bone * Infection in target area * IO insertion in past 24 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone * Allergy to contrast media * Imprisoned * Pregnant * Requires English language translation other than Spanish * Has received proximal humerus IO access with an IO catheter other than the EZ-IO 45 millimeter (mm) needle set system * Has existing proximal humerus IO access using the EZ-IO 45 mm needle set but IO catheter is mal-positioned or dislodged
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequacy of Computed Tomography (CT) Image | at time of CT examination average time is within 24 hours | Adequacy of CT image graded as adequate or inadequate indicating the ability to effectively administer the contrast medium needed for the indicated CT examination. |
| Incidence of Complication With Administration of Contrast for Computed Tomography (CT) Examination | at time of CT examination average time is within 30 minutes | incidence of complications associated with the administration of contrast through the proximal humerus intraosseous (IO) route for CT examination |
Countries
United States
Contacts
STUDY_DIRECTORThomas Philbeck, PhD
Sponsor Company- Vidacare Corporation
Participant flow
Recruitment details
observational study with patients enrolled in the emergency department
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42.25 years STANDARD_DEVIATION 11.18 |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
None listed