Patients Requiring Urgent Vascular AccessNCT01235078
Observation of Intraosseous Vascular Access in the Emergency Department
An observational study of Patients Requiring Urgent Vascular Access, run by Vidacare Corporation at 6 sites in United States.
Trial summary
The purpose of this study is to evaluate the use of powered intraosseous vascular access (EZ-IO by Vidacare) in the emergency department for patients requiring urgent vascular access. Data collected will be compared to historical data on central venous catheter use in the emergency department. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients Requiring Urgent Vascular Access
- What is being tested?
- EZ-IO
- Type of treatment
- Medical device
- How many people
- 105 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2010to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients requiring urgent vascular access
Who may be able to join
- Patients requiring vascular access who would otherwise receive a central venous catheter due to lack of other options.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Texas Tech University Medical Center
El Paso, Texas, 79905
Gulf Breeze Hospital
Gulf Breeze, Florida, 32561
Methodist Healthcare, University Hospital
Memphis, Tennessee, 38104
Omaha Children's Hospital and Medical Center
Omaha, Nebraska, 68198
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Baptist Hospital Pensacola
Pensacola, Florida, 32522
About this study
Official title: An Observational Study of Intraosseous Vascular Access Compared to Central Venous Catheters in the Emergency Department
The purpose of this study is to evaluate the use of powered intraosseous vascular access (EZ-IO by Vidacare) in the emergency department for patients requiring urgent vascular access. Data collected will be compared to historical data on central venous catheter use in the emergency department. The primary hypothesis is that powered intraosseous vascular access will decrease the amount of time needed to obtain vascular access.
- Being tested
- EZ-IO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EZ-IODevice
Also called EZ-IO by Vidacare, Powered intraosseous vascular access
powered intraosseous vascular access system
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous vascular access | subjects with urgent vascular access needs in whom intraosseous vascular access has been attempted and/or established. Receives: Device: EZ-IO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to vascular access
Time from opening intraosseous device packaging to initial infusion of drugs or fluids via the intraosseous route.
Measured: at time of patient's arrival to emergency department, average within 10 minutes
Secondary outcomes (1)
Incidence of complications with intraosseous device
Reported complications by intraosseous device operators.
Measured: time subject has intraosseous vascular access, an average of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Requiring Urgent Vascular AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vidacare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235078
- Sponsor's protocol ID
- 2010-04
- Status last verified
- Jun 2012
- First submitted
- 3 Nov 2010
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Intraosseous Vascular Access Compared to Central Venous Catheters in the Emergency Department
- ClinicalTrials.gov ID
- NCT01235078
- Acronym / sponsor ID
- 2010-04
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Vidacare CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 5 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the use of powered intraosseous vascular access (EZ-IO by Vidacare) in the emergency department for patients requiring urgent vascular access. Data collected will be compared to historical data on central venous catheter use in the emergency department. The primary hypothesis is that powered intraosseous vascular access will decrease the amount of time needed to obtain vascular access.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraosseous vascular access | – | Device: EZ-IOsubjects with urgent vascular access needs in whom intraosseous vascular access has been attempted and/or established. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients requiring urgent vascular access
Key inclusion criteria (1 listed)
- Patients requiring vascular access who would otherwise receive a central venous catheter due to lack of other options.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EZ-IOAlso: EZ-IO by Vidacare, Powered intraosseous vascular accesspowered intraosseous vascular access system | Device | Intraosseous vascular access |
Primary outcome
Time to vascular access
Time frame: at time of patient's arrival to emergency department, average within 10 minutes
Time from opening intraosseous device packaging to initial infusion of drugs or fluids via the intraosseous route.
1 secondary outcome
Incidence of complications with intraosseous device
Time frame: time subject has intraosseous vascular access, an average of 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Requiring Urgent Vascular Access, run by Vidacare Corporation at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to vascular access (time frame: at time of patient's arrival to emergency department, average within 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.