Intraosseous Vascular AccessNCT01866475
Continuous Intraosseous Vascular Access Over 48 Hours
A study testing EZ-IO in people with Intraosseous Vascular Access, run by Vidacare Corporation at 1 site in United States.
Trial summary
A prospective study to determine the safety of intraosseous (IO) access for a period up to 48 hours in healthy adult volunteers and volunteers with a history of mild to moderate renal disease and/or controlled diabetes. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraosseous Vascular Access
- What is being tested?
- EZ-IO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21 years or older
- Self Identifying as having poor vascular access
- Healthy or Having at least one of the following conditions:
- Controlled diabetes, as evidenced by a glycosylated hemoglobin A1c (HbA1c) value of less than or equal to 8% at the time of screening. or
- Renal disease, Stages 1 to 3, as evidenced by the presence of albuminuria at the time of screening. Subjects albumin-creatinine ratio (ACR) must fall within the microalbuminuria or macroalbuminuria values: Microalbuminuria - ACR 17-250 mcg/mg for men; 25-355 mcg/mg for women or, Macroalbuminuria- ACR >250 mcg/mg for men; >355 mcg/mg for women
Who cannot join
- Imprisoned
- Self identifying as pregnant
- Cognitively impaired
- Fracture in target bone
- Excessive tissue and/or absence of adequated anatomical landmarks in target bone
- Signs and symptoms of infection in target area
Show all 19Show fewer
- IO insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone
- Intravenous infusion within the past 30 days
- Current use of anti-coagulants
- Previous adverse reaction or known allergy to Lidocaine
- Current cardiac condition requiring pacemaker
- Currently taking beta blockers or calcium channel blockers for heart arrhythmia (use of beta blockers or calcium channel blocker for hypertension is allowed when indication of hypertension can be confirmed by physician
- Previous surgery for peripheral arterial disease
- History of ulcers to the extremities
- History of bilateral lymph node dissection in the arms or legs
- Known sickle-cell disease
- signs or symptoms of vascular disease or vascular insufficiencies to the extremities, as identified upon physical examination
- History of peripheral vascular disease
- Hyperkalemia as evidenced by potassium level greater than 5.1 mmol/L the upper limit of hte normal reference range at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Determine the Safety of Continuous Intraosseous Vascular Access Over a Period of 48 Hours
A prospective study to determine the safety of intraosseous (IO) access for a period up to 48 hours in healthy adult volunteers and volunteers with a history of mild to moderate renal disease and/or controlled diabetes.
Read the detailed description
A prospective, study to determine the safety of intraosseous (IO) access for a period up to 48 hours, in healthy adult volunteers and volunteers with a history of being health-compromised, including patients with mild to moderate renal disease (National Health and Nutrition Examination Survey Stage 1 to 3) and/or patients with controlled diabetes. Subjects will be randomized to receive IO access in the proximal tibia insertion site or the proximal humerus insertion site using the EZ-IO intraosseous vascular access system. The hypothesis is that there will be no serious complications for the subjects during a 48 hour IO catheter dwell time in either place.
- Conditions
- Intraosseous Vascular Access
- Being tested
- EZ-IO
- Keywords
- IO access, Intraosseous vascular access, EZ-IO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EZ-IODevice
To have an EZ-IO placed up to 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Renal Disease | Active comparator | Those with mild to moderate renal disease and had an EZ-IO for 48 hours Receives: Device: EZ-IO |
| Diabetes | Active comparator | Those with controlled diabetes and had an EZ-IO for 48 hours Receives: Device: EZ-IO |
| Renal disease and diabetes | Active comparator | Those with both mild to moderate renal disease and controlled diabetes and had an EZ-IO for 48 hours Receives: Device: EZ-IO |
| Healthy adults | Active comparator | Those who are healthy, defined as lacking co-morbidities that are a study exclusion, and had an EZ-IO for 48 hours Receives: Device: EZ-IO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Complications From Intraosseous (IO) Access
Presence of serious complications from 48 hour intraosseous (IO) vascular access using EZ-IO.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startNov 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intraosseous 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vidacare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emanuel DeNoia, MD, Principal investigator, ICON plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866475
- Sponsor's protocol ID
- 2011-16
- Status last verified
- Mar 2024
- First submitted
- 28 May 2013
- Last updated
- 9 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Safety of Continuous Intraosseous Vascular Access Over a Period of 48 Hours
- ClinicalTrials.gov ID
- NCT01866475
- Acronym / sponsor ID
- 2011-16
- Conditions
- Intraosseous Vascular Access
- Keywords
- IO access, Intraosseous vascular access, EZ-IO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Vidacare CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Posted 9 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective study to determine the safety of intraosseous (IO) access for a period up to 48 hours in healthy adult volunteers and volunteers with a history of mild to moderate renal disease and/or controlled diabetes.
Detailed description
A prospective, study to determine the safety of intraosseous (IO) access for a period up to 48 hours, in healthy adult volunteers and volunteers with a history of being health-compromised, including patients with mild to moderate renal disease (National Health and Nutrition Examination Survey Stage 1 to 3) and/or patients with controlled diabetes. Subjects will be randomized to receive IO access in the proximal tibia insertion site or the proximal humerus insertion site using the EZ-IO intraosseous vascular access system. The hypothesis is that there will be no serious complications for the subjects during a 48 hour IO catheter dwell time in either place.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Renal Disease | Active comparator | Device: EZ-IOThose with mild to moderate renal disease and had an EZ-IO for 48 hours |
| Diabetes | Active comparator | Device: EZ-IOThose with controlled diabetes and had an EZ-IO for 48 hours |
| Renal disease and diabetes | Active comparator | Device: EZ-IOThose with both mild to moderate renal disease and controlled diabetes and had an EZ-IO for 48 hours |
| Healthy adults | Active comparator | Device: EZ-IOThose who are healthy, defined as lacking co-morbidities that are a study exclusion, and had an EZ-IO for 48 hours |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21 years or older
- Self Identifying as having poor vascular access
- Healthy or Having at least one of the following conditions:
- Controlled diabetes, as evidenced by a glycosylated hemoglobin A1c (HbA1c) value of less than or equal to 8% at the time of screening. or
- Renal disease, Stages 1 to 3, as evidenced by the presence of albuminuria at the time of screening. Subjects albumin-creatinine ratio (ACR) must fall within the microalbuminuria or macroalbuminuria values: Microalbuminuria - ACR 17-250 mcg/mg for men; 25-355 mcg/mg for women or, Macroalbuminuria- ACR >250 mcg/mg for men; >355 mcg/mg for women
Key exclusion criteria (19 listed)
- Imprisoned
- Self identifying as pregnant
- Cognitively impaired
- Fracture in target bone
- Excessive tissue and/or absence of adequated anatomical landmarks 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-IOTo have an EZ-IO placed up to 48 hours | Device | Diabetes, Healthy adults, Renal Disease, Renal disease and diabetes |
Primary outcome
Serious Complications From Intraosseous (IO) Access
Time frame: 48 hours
Presence of serious complications from 48 hour intraosseous (IO) vascular access using EZ-IO.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Emanuel DeNoia, MD principal investigator
ICON plc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EZ-IO in people with Intraosseous Vascular Access, run by Vidacare Corporation 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 5 inclusion and 19 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 9 Apr 2024. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serious Complications From Intraosseous (IO) Access (time frame: 48 hours). 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 9 Apr 2024.