Intraosseous AccessNCT02021617
Infusion Flow Rates and Blood Sampling
A study testing Intraosseous access in people with Intraosseous Access and Infusion Rates, run by Vidacare Corporation at 1 site in United States.
Trial summary
To evaluate infusion flow rates attainable when using the proximal humerus and proximal tibia IO vascular access sites. To evaluate the intraosseous infusion physiology when using the proximal humerus and proximal tibia IO infusion sites. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraosseous Access, Infusion Rates, Intraosseous Blood
- What is being tested?
- Intraosseous access
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2013to 15 Nov 2013
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21 years or older;
- Have no amputation of the upper or lower extremities;
- Able to lay flat on a table for up to 2 hours;
- Self-reported as healthy;
- Negative urine pregnancy test day of in-house study procedures (female subjects)
Who cannot join
- Have a known active infection in the body;
- Imprisoned;
- Pregnant ;
- Cognitively impaired ;
- Fracture in humerus or tibia, or significant trauma to the site;
- Excessive tissue and/or absence of adequate anatomical landmarks at proximal humerus and proximal tibia IO insertion sites;
Show all 21Show fewer
- Infection in target area;
- Humeral/tibial IO insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in humerus or tibia;
- Current use of anti-coagulants;
- Current cardiac condition requiring pacemaker or anti-arrhythmic drugs;
- Prior adverse reaction to lidocaine;
- History of impaired renal function;
- Prior adverse reaction to contrast media;
- Allergy to iodine containing medications;
- Allergy to shellfish;
- Have taken analgesics/anesthetics the day of in-house study procedures;
- Volunteers with any of the following characteristics may be excluded from the study at the discretion of the PI;
- Allergy to any food or drug;
- History of impaired hepatic function;
- History of cardiac disease;
- History of pheochromocytoma
Trial locations and contacts
1 site in 1 country.
United States1 site
Bulverde Spring Branch EMS
Spring Branch, Texas, 78070
About this study
Official title: A Study Comparing Infusion Flow Rates Using the Proximal Humerus and Proximal Tibia Intraosseous Vascular Access Insertion Sites and Comparing Intraosseous and Venous Blood for Laboratory Specimen Sampling
- To evaluate infusion flow rates attainable when using the proximal humerus and proximal tibia IO vascular access sites.
- To evaluate the intraosseous infusion physiology when using the proximal humerus and proximal tibia IO infusion sites.
- To further evaluate the relationship between IO and venous blood when used for laboratory testing.
- To determine the time from IO needle insertion to IO access established.
Read the detailed description
Often in emergencies and other medical situations, doctors must gain vascular access (access to the blood stream) in order to give drugs and/or fluids to patients. The most common way to gain vascular access is to place a needle into a vein through the skin, but sometimes this is not possible. Another way to gain vascular access is to insert a needle through the skin, into the bone and give drugs and/or fluids to patients through the center of the bone, which is hollow and contains blood vessels. This is called intraosseous (IO) vascular access. One device used to gain intraosseous vascular access is called the EZ-IO® Intraosseous Vascular Access System and it can be used in the proximal humerus (upper arm bone), proximal tibia (upper shin bone), and the distal tibia (lower shin bone). The EZ-IO has been cleared by the FDA to establish IO vascular access in the sites identified above for the infusion of drugs and fluids anytime vascular access is difficult to obtain in emergent, urgent, or medically necessary cases.
IV fluids and medicines must be infused into a patient's blood stream at different speeds depending upon what is being infused. Some IV fluids and medications must be given slowly and some must be given quickly. How fast IV fluids and medicines are infused into the blood stream is called infusion flow rate. One way to increase the infusion flow rate is to apply pressure to (squeeze) the IV fluid bag being used. This is done by applying a pressure bag around the IV fluid bag, which acts like a blood pressure cuff and inflates when pumped up. The purpose of this study is to see how quickly IV fluids can be infused into your blood stream through the proximal humerus (upper arm bone) and the proximal tibia (upper shin bone) by measuring the infusion flow rate. We want to see how fast IV fluids can be infused into your blood stream at different infusion pressures. We will also look at the route the fluid travels from the IO needle in your arm and leg to the heart.
Another purpose of the study is to determine if blood drawn from the bone can be used for laboratory tests the same as blood drawn from a vein or collected using a finger stick.
- Conditions
- Intraosseous Access, Infusion Rates, Intraosseous Blood, Venous Blood
- Being tested
- Intraosseous access
- Keywords
- Intraosseous Access, EZ-IO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraosseous accessDevice
Also called EZ-IO
The EZ-IO Intraosseous Vascular Access System (Vidacare Corporation, Shavano Park, TX, USA) has been cleared by the U.S. Food and Drug Administration, Health Canada, and the European Union for the administration of drugs and fluids anytime vascular access is difficult to obtain in emergent, urgent, or medically necessary cases. It consists of a driver-a small battery-powered drill-and a needle set designed for insertion into the IO space of the proximal tibia, distal tibia, or proximal humerus. Needles are 15 gauge and available in three lengths: 15 mm, 25 mm, and 45 mm. In this study the 45 mm EZ-IO needle set will be used for all humeral placements and the 25 mm needle set will be used for all tibial placements.
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous Access | Experimental | This study will evaluate the proximal humerus and proximal tibia IO infusion sites for infusion flow rates attainable at specified infusion pressures. We will evaluate the IO infusion pathway to determine the mean time from IO contrast injection at the proximal humerus and proximal tibia sites to delivery to central circulation. This study will provide additional data regarding the relationship between IO and IV blood when used for routine laboratory analysis, adding to the current sample size. Lastly, this study will provide data to determine the average time from IO needle insertion to access of the IO space for immediate drug administration, and the average time from IO needle insertion to the ability to infuse fluids in the conscious subject. Intraosseous access. Receives: Device: Intraosseous access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infusion Flow Rates
To evaluate infusion flow rates attainable when using the proximal humerus and proximal tibia IO vascular access. Intraosseous
Measured: 1 Day
Secondary outcomes (2)
IO blood versus venous blood
To evaluate that IO blood is equal to venous blood when used for laboratory testing when IO blood is the only option in an emergency situation. Intraosseous
Measured: 1 Day
IO needle insertion to IO access
To determine the time from IO needle insertion to IO access established. Intraosseous
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study start5 Nov 2013
- Primary completion15 Nov 2013
- Study completion15 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraosseous 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vidacare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry J. Miller, MD, Principal investigator, Vidacare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021617
- Sponsor's protocol ID
- 2013-14
- Status last verified
- Dec 2013
- First submitted
- 24 Oct 2013
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing Infusion Flow Rates Using the Proximal Humerus and Proximal Tibia Intraosseous Vascular Access Insertion Sites and Comparing Intraosseous and Venous Blood for Laboratory Specimen Sampling
- ClinicalTrials.gov ID
- NCT02021617
- Acronym / sponsor ID
- 2013-14
- Conditions
- Intraosseous Access, Infusion Rates, Intraosseous Blood, Venous Blood
- Keywords
- Intraosseous Access, EZ-IO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vidacare CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2013 (actual)
- Primary completion
- 15 Nov 2013 (actual)
- Study completion
- 15 Nov 2013 (actual)
- First posted
- 27 Dec 2013 (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.
- To evaluate infusion flow rates attainable when using the proximal humerus and proximal tibia IO vascular access sites.
- To evaluate the intraosseous infusion physiology when using the proximal humerus and proximal tibia IO infusion sites.
- To further evaluate the relationship between IO and venous blood when used for laboratory testing.
- To determine the time from IO needle insertion to IO access established.
Detailed description
Often in emergencies and other medical situations, doctors must gain vascular access (access to the blood stream) in order to give drugs and/or fluids to patients. The most common way to gain vascular access is to place a needle into a vein through the skin, but sometimes this is not possible. Another way to gain vascular access is to insert a needle through the skin, into the bone and give drugs and/or fluids to patients through the center of the bone, which is hollow and contains blood vessels. This is called intraosseous (IO) vascular access. One device used to gain intraosseous vascular access is called the EZ-IO® Intraosseous Vascular Access System and it can be used in the proximal humerus (upper arm bone), proximal tibia (upper shin bone), and the distal tibia (lower shin bone). The EZ-IO has been cleared by the FDA to establish IO vascular access in the sites identified above for the infusion of drugs and fluids anytime vascular access is difficult to obtain in emergent, urgent, or medically necessary cases.
IV fluids and medicines must be infused into a patient's blood stream at different speeds depending upon what is being infused. Some IV fluids and medications must be given slowly and some must be given quickly. How fast IV fluids and medicines are infused into the blood stream is called infusion flow rate. One way to increase the infusion flow rate is to apply pressure to (squeeze) the IV fluid bag being used. This is done by applying a pressure bag around the IV fluid bag, which acts like a blood pressure cuff and inflates when pumped up. The purpose of this study is to see how quickly IV fluids can be infused into your blood stream through the proximal humerus (upper arm bone) and the proximal tibia (upper shin bone) by measuring the infusion flow rate. We want to see how fast IV fluids can be infused into your blood stream at different infusion pressures. We will also look at the route the fluid travels from the IO needle in your arm and leg to the heart.
Another purpose of the study is to determine if blood drawn from the bone can be used for laboratory tests the same as blood drawn from a vein or collected using a finger stick.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraosseous Access | Experimental | Device: Intraosseous accessThis study will evaluate the proximal humerus and proximal tibia IO infusion sites for infusion flow rates attainable at specified infusion pressures. We will evaluate the IO infusion pathway to determine the mean time from IO contrast injection at the proximal humerus and proximal tibia sites to delivery to central circulation. This study will provide additional data regarding the relationship between IO and IV blood when used for routine laboratory analysis, adding to the current sample size. Lastly, this study will provide data to determine the average time from IO needle insertion to access of the IO space for immediate drug administration, and the average time from IO needle insertion to the ability to infuse fluids in the conscious subject. Intraosseous access. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21 years or older;
- Have no amputation of the upper or lower extremities;
- Able to lay flat on a table for up to 2 hours;
- Self-reported as healthy;
- Negative urine pregnancy test day of in-house study procedures (female subjects)
Key exclusion criteria (21 listed)
- Have a known active infection in the body;
- Imprisoned;
- Pregnant ;
- Cognitively impaired ;
- Fracture in humerus or tibia, or significant trauma to the site;
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 |
|---|---|---|
| Intraosseous accessAlso: EZ-IOThe EZ-IO Intraosseous Vascular Access System (Vidacare Corporation, Shavano Park, TX, USA) has been cleared by the U.S. Food and Drug Administration, Health Canada, and the European Union for the administration of drugs and fluids anytime vascular access is difficult to obtain in emergent, urgent, or medically necessary cases. It consists of a driver-a small battery-powered drill-and a needle set designed for insertion into the IO space of the proximal tibia, distal tibia, or proximal humerus. Needles are 15 gauge and available in three lengths: 15 mm, 25 mm, and 45 mm. In this study the 45 mm EZ-IO needle set will be used for all humeral placements and the 25 mm needle set will be used for all tibial placements. | Device | Intraosseous Access |
Primary outcome
Infusion Flow Rates
Time frame: 1 Day
To evaluate infusion flow rates attainable when using the proximal humerus and proximal tibia IO vascular access. Intraosseous
2 secondary outcomes
IO blood versus venous blood
Time frame: 1 Day
IO needle insertion to IO access
Time frame: 1 Day
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 14 Oct 2026.
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.
Larry J. Miller, MD principal investigator
Vidacare Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraosseous access in people with Intraosseous Access and Infusion Rates, 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 21 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 14 Oct 2026. 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 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?
Infusion Flow Rates (time frame: 1 Day). 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 14 Oct 2026.