Catheters, IndwellingNCT00785252
EZIO Compared to Central Venous Lines for Emergency Vascular Access
A study testing Powered Intraosseous device (EZIO) and standard central line in people with Catheters, Indwelling and Central Venous Line, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Multicenter randomized study to compare powered intraosseous access to standard central line access for the administration of fluids and drugs for patients in the Emergency Dept. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheters, Indwelling, Central Venous Line, Intraosseous Needle
- What is being tested?
- Powered Intraosseous device (EZIO) and standard central line
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2010
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old Requires central access after peripheral access attempts have failed or are not otherwise feasible
Who cannot join
- Fracture in target bone Not able to sign informed consent Excessive tissue or absence of adequate anatomical landmarks Known or suspected coagulopathies Pregnancy Patients in custody Patients with suspected great vessel injury Not fluid in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Dept of Emergency Medicine, The George Washington University Medical Center
Washington D.C., District of Columbia, 20037
About this study
Official title: Randomized Study of the EZIO Compared to Central Venous Lines Used for Emergency Vascular Access
Multicenter randomized study to compare powered intraosseous access to standard central line access for the administration of fluids and drugs for patients in the Emergency Dept.
- Being tested
- Powered Intraosseous device (EZIO), standard central line
- Keywords
- Catheters, Indwelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered Intraosseous device (EZIO)Device
EZIO
standard central lineDevice
placement of a central line
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | EZIO Receives: Device: Powered Intraosseous device (EZIO) |
| 2 | Experimental | Central line Receives: Device: standard central line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken to place the device
Measured: ED visit
Secondary outcomes (2)
Incidence of complications
Measured: ED visit
Costs for each of the two methods
Measured: Ed visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Why it stopped: Sponsor termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheters, IndwellingStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Vidacare Corporation
- Responsible party
- Sponsor
- Investigators
- Jeremty Brown, MD, Principal investigator, George Washington UniversityJeremy Brown, Principal investigator, Dept of Emergency Medicine, GWU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785252
- Sponsor's protocol ID
- 100731 (completed)
- Status last verified
- Sep 2021
- First submitted
- 3 Nov 2008
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of the EZIO Compared to Central Venous Lines Used for Emergency Vascular Access
- ClinicalTrials.gov ID
- NCT00785252
- Acronym / sponsor ID
- 100731 (completed)
- Keywords
- Catheters, Indwelling
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor termination
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Vidacare Corporation
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 5 Nov 2008 (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.
Multicenter randomized study to compare powered intraosseous access to standard central line access for the administration of fluids and drugs for patients in the Emergency Dept.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Powered Intraosseous device (EZIO)EZIO |
| 2 | Experimental | Device: standard central lineCentral line |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Over 18 years old Requires central access after peripheral access attempts have failed or are not otherwise feasible
Key exclusion criteria (1 listed)
- Fracture in target bone Not able to sign informed consent Excessive tissue or absence of adequate anatomical landmarks Known or suspected coagulopathies Pregnancy Patients in custody Patients with suspected great vessel injury Not fluid in English
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 |
|---|---|---|
| Powered Intraosseous device (EZIO)EZIO | Device | 1 |
| standard central lineplacement of a central line | Device | 2 |
Primary outcome
Time taken to place the device
Time frame: ED visit
2 secondary outcomes
Incidence of complications
Time frame: ED visit
Costs for each of the two methods
Time frame: Ed visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Related InfoLink provided by the sponsor.
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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.
Jeremty Brown, MD principal investigator
George Washington University
Jeremy Brown principal investigator
Dept of Emergency Medicine, GWU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powered Intraosseous device (EZIO) and standard central line in people with Catheters, Indwelling and Central Venous Line, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site 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 1 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: withdrawn, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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 taken to place the device (time frame: ED visit). 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 28 Sep 2021.