Trial Outcomes & Findings for Intraosseous Versus Intravenous Vascular Access During Cardiac Arrest (NCT NCT01119807)

NCT ID: NCT01119807

Last Updated: 2022-06-03

Results Overview

This measure will be assessed on the day an individual experiences cardiac arrest and will not be followed upon admission to the emergency department.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 182 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2022-06-03

Participant Flow

Participant milestones

Measure	Intravenous Intravenous access during OHCA: First attempt will be a peripheral IV in the AC. If this fails, second attempt will be a tibial IO, followed by a humeral IO when indicated.	Humeral IO Humeral IO insertion: First attempt will be a humeral IO. Second attempt should occur at the tibia if the first humeral IO fails. Subsequent attempts will be for a peripheral IV or additional IOs as determined by the paramedic.	Tibial IO TIbial IO insertion: First attempt will be a tibial IO. Second attempt should occur on the opposite tibia if the first IO fails. Subsequent attempts will be for a humeral IO or peripheral IV as selected by the paramedic.
Overall Study STARTED	67	51	64
Overall Study COMPLETED	67	51	64
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intraosseous Versus Intravenous Vascular Access During Cardiac Arrest

Baseline characteristics by cohort

Measure	Intravenous n=67 Participants Intravenous access during OHCA: First attempt will be a peripheral IV in the AC. If this fails, second attempt will be a tibial IO, followed by a humeral IO when indicated.	Humeral IO n=51 Participants Humeral IO insertion: First attempt will be a humeral IO. Second attempt should occur at the tibia if the first humeral IO fails. Subsequent attempts will be for a peripheral IV or additional IOs as determined by the paramedic.	Tibial IO n=64 Participants TIbial IO insertion: First attempt will be a tibial IO. Second attempt should occur on the opposite tibia if the first IO fails. Subsequent attempts will be for a humeral IO or peripheral IV as selected by the paramedic.	Total n=182 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 2 • n=5 Participants	61 years STANDARD_DEVIATION 2 • n=7 Participants	66 years STANDARD_DEVIATION 2 • n=5 Participants	64 years STANDARD_DEVIATION 1 • n=4 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	15 Participants n=7 Participants	23 Participants n=5 Participants	80 Participants n=4 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	36 Participants n=7 Participants	41 Participants n=5 Participants	102 Participants n=4 Participants
Race/Ethnicity, Customized Race · Caucasian	32 Participants n=5 Participants	21 Participants n=7 Participants	35 Participants n=5 Participants	88 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	35 Participants n=5 Participants	30 Participants n=7 Participants	29 Participants n=5 Participants	94 Participants n=4 Participants
Region of Enrollment United States	67 participants n=5 Participants	51 participants n=7 Participants	64 participants n=5 Participants	182 participants n=4 Participants

PRIMARY outcome

Timeframe: 1 day

This measure will be assessed on the day an individual experiences cardiac arrest and will not be followed upon admission to the emergency department.

Outcome measures

Measure	Intravenous n=67 Participants Intravenous access during OHCA: First attempt will be a peripheral IV in the AC. If this fails, second attempt will be a tibial IO, followed by a humeral IO when indicated.	Humeral IO n=51 Participants Humeral IO insertion: First attempt will be a humeral IO. Second attempt should occur at the tibia if the first humeral IO fails. Subsequent attempts will be for a peripheral IV or additional IOs as determined by the paramedic.	Tibial IO n=64 Participants TIbial IO insertion: First attempt will be a tibial IO. Second attempt should occur on the opposite tibia if the first IO fails. Subsequent attempts will be for a humeral IO or peripheral IV as selected by the paramedic.
First Attempt Success Rate Between the Tibial IO, Humeral IO, and Peripheral IV.	26 Participants	17 Participants	58 Participants

Adverse Events

Intravenous

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Humeral IO

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tibial IO

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

Jonathan R Studnek PhD

Mecklenburg EMS Agency

Phone: 7049436046

Email: jonst@medic911.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place