Intraosseus AccessNIONCT02275520
Intraosseous Access
A study testing NIO Adult device, Bone Iniection Gun and EZ-IO in people with Intraosseus Access and Manikin, run by International Institute of Rescue Research and Education at 1 site in Poland.
Trial summary
The investigators will compare the success rates and time to successful IO access during simulated adult resuscitation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraosseus Access, Manikin, Resuscitation
- What is being tested?
- NIO Adult device, Bone Iniection Gun and EZ-IO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2014to May 2015
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Give voluntary consent to participate in the study
- paramedic
- more than 1 year experience in medicine
Who cannot join
- Not meet the above criteria
- Wrist or Low back diseases
Trial locations and contacts
1 site in 1 country.
Poland1 site
International Institute of Rescue Research and Education
Warsaw, Masovia, 03-122
About this study
Official title: Comparison of NIO, BIG, EZ-IO, Jamshidi and Cook Intraosseous Devices in Adult Patients Under Resuscitation by Paramedics: a Randomized Crossover Manikin Trial.
The investigators will compare the success rates and time to successful IO access during simulated adult resuscitation.
- Conditions
- Intraosseus Access, Manikin, Resuscitation
- Being tested
- NIO Adult device, Bone Iniection Gun, EZ-IO, Jamshidi Intraosseous Needle, Cook Intraosseous Needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIO Adult deviceDevice
Also called NIO
IO access-1
Bone Iniection GunDevice
Also called BIG
IO access-2
EZ-IODevice
IO access-3
Jamshidi Intraosseous NeedleDevice
Also called Jamshidi
IO access-4
Cook Intraosseous NeedleDevice
Also called Cook
IO access-5
| Study group | Role | What they receive |
|---|---|---|
| IO access | Other | Performed intraosseus access device during simulated cardiopulmonary resuscitation Receives: Device: NIO Adult device; Device: Bone Iniection Gun; Device: EZ-IO; Device: Jamshidi Intraosseous Needle; Device: Cook Intraosseous Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to IO needle insertion
time from picking up a intraosseous access device, to successful IO needle insertion in the bone
Measured: 1 day
Secondary outcomes (3)
time to IO needle stabilization
time from picking up a intraosseus access device to correct fixation IO needle
Measured: 1 day
time to intraosseuss infusion
begining with picking up a intraosseuss access device and ending with the IV line tubing was connected to the inseted IO needle
Measured: 1 day
Ease of use
To access subjective opinion about the difficulty of the procedure, participants were asked to rate it on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).
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 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraosseus 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Institute of Rescue Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukasz Szarpak, National Institute of Cardiology, Warsaw, Poland
- Investigators
- Lukasz Szarpak, Principal investigator, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275520
- Sponsor's protocol ID
- IO2014
- Acronym
- NIO
- Status last verified
- May 2015
- First submitted
- 22 Oct 2014
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of NIO, BIG, EZ-IO, Jamshidi and Cook Intraosseous Devices in Adult Patients Under Resuscitation by Paramedics: a Randomized Crossover Manikin Trial.
- ClinicalTrials.gov ID
- NCT02275520
- Acronym / sponsor ID
- NIO / IO2014
- Conditions
- Intraosseus Access, Manikin, Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- International Institute of Rescue Research and EducationUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 Oct 2014 (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 investigators will compare the success rates and time to successful IO access during simulated adult resuscitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IO access | Other | Device: NIO Adult device, Device: Bone Iniection Gun, Device: EZ-IO, Device: Jamshidi Intraosseous Needle, Device: Cook Intraosseous NeedlePerformed intraosseus access device during simulated cardiopulmonary resuscitation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Give voluntary consent to participate in the study
- paramedic
- more than 1 year experience in medicine
Key exclusion criteria (2 listed)
- Not meet the above criteria
- Wrist or Low back diseases
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 |
|---|---|---|
| NIO Adult deviceAlso: NIOIO access-1 | Device | IO access |
| Bone Iniection GunAlso: BIGIO access-2 | Device | IO access |
| EZ-IOIO access-3 | Device | IO access |
| Jamshidi Intraosseous NeedleAlso: JamshidiIO access-4 | Device | IO access |
| Cook Intraosseous NeedleAlso: CookIO access-5 | Device | IO access |
Primary outcome
time to IO needle insertion
Time frame: 1 day
time from picking up a intraosseous access device, to successful IO needle insertion in the bone
3 secondary outcomes
time to IO needle stabilization
Time frame: 1 day
time to intraosseuss infusion
Time frame: 1 day
Ease of use
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 13 May 2015.
Related trials for Intraosseus Access
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To Compare the Time Required to Administer 1 mg of Epinephrine, as Well as the Total Procedure
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.
Lukasz Szarpak principal investigator
National Institute of Cardiology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIO Adult device, Bone Iniection Gun and EZ-IO in people with Intraosseus Access and Manikin, run by International Institute of Rescue Research and Education at 1 site in Poland.
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 3 inclusion and 2 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 13 May 2015. 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 Poland. 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 IO needle insertion (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 13 May 2015.