Trial Outcomes & Findings for Observational Study of CT Dye Administration Through the Intraosseous Vascular Access Route (NCT NCT01531686)

Results Overview

Adequacy of CT image graded as adequate or inadequate indicating the ability to effectively administer the contrast medium needed for the indicated CT examination.

Recruitment status

TERMINATED

Target enrollment

8 participants

Primary outcome timeframe

at time of CT examination average time is within 24 hours

Results posted on

2026-02-11

Participant Flow

observational study with patients enrolled in the emergency department

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Observational Study of CT Dye Administration Through the Intraosseous Vascular Access Route

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Proximal Humerus Intraosseous (IO) Computed Tomography (CT) Contrast n=8 Participants 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.
Age, Continuous	42.25 years STANDARD_DEVIATION 11.18 • n=41 Participants
Sex: Female, Male Female	4 Participants n=41 Participants
Sex: Female, Male Male	4 Participants n=41 Participants
Region of Enrollment United States	8 Participants n=41 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Proximal Humerus Intraosseous (IO) Computed Tomography (CT) Contrast n=8 Participants Adult patients receiving administration of contrast for the purpose of computed tomography (CT) examination via intraosseous vascular access established in the proximal humerus, in the emergency department.
Adequacy of Computed Tomography (CT) Image CT Image graded as adequate	7 Participants
Adequacy of Computed Tomography (CT) Image CT image graded as inadequate	1 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Proximal Humerus Intraosseous (IO) Computed Tomography (CT) Contrast n=8 Participants Adult patients receiving administration of contrast for the purpose of computed tomography (CT) examination via intraosseous vascular access established in the proximal humerus, in the emergency department.
Incidence of Complication With Administration of Contrast for Computed Tomography (CT) Examination	1 complications

Adverse Events

Proximal Humerus Intraosseous (IO) Computed Tomography (CT) Contrast

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tatiana Puga

Teleflex

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60