Trial Outcomes & Findings for Intraosseous Access in the Emergency Department for Patients With Failed Attempts at Intravenous Access: A Randomized Trial Examining Resource Utilization and Patient Satisfaction (NCT NCT01676350)
NCT ID: NCT01676350
Last Updated: 2022-03-23
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
at time of vascular access
Results posted on
2022-03-23
Participant Flow
Participant milestones
| Measure |
Standard of Care
If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.
|
&Apos;IO Access Using EZ-IO®
If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.
IO access using EZ-IO®: IO line placed using an FDA-approved device called an EZ-IO®.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraosseous Access in the Emergency Department for Patients With Failed Attempts at Intravenous Access: A Randomized Trial Examining Resource Utilization and Patient Satisfaction
Baseline characteristics by cohort
| Measure |
Standard of Care
n=11 Participants
Standard of care
|
IO Access
n=11 Participants
IO access
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at time of vascular accessOutcome measures
| Measure |
Standard of Care
n=11 Participants
If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.
|
&Apos;IO Access Using EZ-IO®
n=8 Participants
If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.
IO access using EZ-IO®: IO line placed using an FDA-approved device called an EZ-IO®.
|
|---|---|---|
|
Time to Successful Placement of a Functioning USGIV/IO
|
163.7 seconds
Standard Deviation 177.9
|
67.3 seconds
Standard Deviation 98.5
|
PRIMARY outcome
Timeframe: at time of vascular accessOutcome measures
| Measure |
Standard of Care
n=11 Participants
If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.
|
&Apos;IO Access Using EZ-IO®
n=11 Participants
If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. IO lines are placed using an FDA-approved device called an EZ-IO®.
IO access using EZ-IO®: IO line placed using an FDA-approved device called an EZ-IO®.
|
|---|---|---|
|
Number of Successful Placements
|
11 successful placements
|
8 successful placements
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
&Apos;IO Access Using EZ-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