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=99 Participants
|
61 years
STANDARD_DEVIATION 2 • n=107 Participants
|
66 years
STANDARD_DEVIATION 2 • n=206 Participants
|
64 years
STANDARD_DEVIATION 1 • n=157 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
80 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
102 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
32 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
88 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
35 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
94 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=99 Participants
|
51 participants
n=107 Participants
|
64 participants
n=206 Participants
|
182 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: 1 dayThis 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place