Intraosseous AccessIOACSNCT02700867
Trial Comparing Proximal Tibia and Proximal Humerus Infusion Rates Using the NIO Intraosseous Device
A study testing NIO in people with Intraosseous Access and Resuscitation, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The investigators sought to compare the intraosseous access success rates of the proximal tibia and the proximal humerus using new Intraosseous access device "NIO" in an adult cadaver model during simulated resuscitation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraosseous Access, Resuscitation
- What is being tested?
- NIO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2016to Mar 2016
- 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
- paramedics
- without previous experience in intraosseous devices
Who cannot join
- not meet the above criteria
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Warsaw, Department of Emergency Medicine
Warsaw, Masovia, 02-005
About this study
Official title: A Randomized Crossover Cadaver Trial Comparing Proximal Tibia and Proximal Humerus Infusion Rates Using the NIO Intraosseous Device During Simulated Cardiopulmonary Resuscitation Performed by Paramedics
The investigators sought to compare the intraosseous access success rates of the proximal tibia and the proximal humerus using new Intraosseous access device "NIO" in an adult cadaver model during simulated resuscitation.
- Conditions
- Intraosseous Access, Resuscitation
- Being tested
- NIO
- Keywords
- intraosseous access, cardiopulmonary resuscitation, paramedic, simulation, cadaver
- Medical subject headings
- Cadaver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIODevice
Intraosseous access device NIO (Defibtech)
| Study group | Role | What they receive |
|---|---|---|
| Proximal tibia | Experimental | Assumption of intraosseous access into the proximal tibia. Simulation of continous resuscitation was carried out using a system of chest compression LifeLine ARM. Receives: Device: NIO |
| Proximal humerus | Experimental | Assumption of intraosseous access into the proximal humerus. Simulation of continous resuscitation was carried out using a system of chest compression LifeLine ARM. Receives: Device: NIO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Success rate of IO cannulation was defined as successful administration of infusion solutions via the performed IO access. Failure was defined as extravasation or unsuccessful (first) effort of IO insertion.
Measured: 1 day
Secondary outcomes (3)
Time of IO insertion
Procedure time was defined as the duration of picking up the prepared set of IO device from the shelf, preparation of the access set and patients' insertion site including disinfection and draping, insertion procedure of the cannula itself, assembling of the access set and first successful administration of drugs or infusion solutions through the newly established vascular access. The time taken for each infusion attempt was measured offline while reviewing procedures by videotape, and subsequently entered into a computer spreadsheet. Times were measured in seconds.
Measured: 1 day
Ease-of-use
ease-of-use of the NIO in tibia and humerus using a five-point Likert Scale ("the device is easy to use"; 1-strongly disagree, 2-disagree, 3-neither agree nor disagree, 4-agree, 5-strongly agree).
Measured: 1 day
first location
Participants were asked to record their "first location access" tibia or humerus
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 posted7 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Szarpak, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700867
- Sponsor's protocol ID
- 02.006.1MR
- Acronym
- IOACS
- Status last verified
- Mar 2016
- First submitted
- 15 Feb 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Szarpak L, Truszewski Z, Smereka J, Krajewski P, Fudalej M, Adamczyk P, Czyzewski L. A Randomized Cadaver Study Comparing First-Attempt Success Between Tibial and Humeral Intraosseous Insertions Using NIO Device by Paramedics: A Preliminary Investigation. Medicine (Baltimore). 2016 May;95(20):e3724. doi: 10.1097/MD.0000000000003724.
PubMed 27196493
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Cadaver Trial Comparing Proximal Tibia and Proximal Humerus Infusion Rates Using the NIO Intraosseous Device During Simulated Cardiopulmonary Resuscitation Performed by Paramedics
- ClinicalTrials.gov ID
- NCT02700867
- Acronym / sponsor ID
- IOACS / 02.006.1MR
- Conditions
- Intraosseous Access, Resuscitation
- Keywords
- intraosseous access, cardiopulmonary resuscitation, paramedic, simulation, cadaver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Mar 2016 (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 sought to compare the intraosseous access success rates of the proximal tibia and the proximal humerus using new Intraosseous access device "NIO" in an adult cadaver model during simulated resuscitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal tibia | Experimental | Device: NIOAssumption of intraosseous access into the proximal tibia. Simulation of continous resuscitation was carried out using a system of chest compression LifeLine ARM. |
| Proximal humerus | Experimental | Device: NIOAssumption of intraosseous access into the proximal humerus. Simulation of continous resuscitation was carried out using a system of chest compression LifeLine ARM. |
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
- paramedics
- without previous experience in intraosseous devices
Key exclusion criteria (1 listed)
- not meet the above criteria
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 |
|---|---|---|
| NIOIntraosseous access device NIO (Defibtech) | Device | Proximal humerus, Proximal tibia |
Primary outcome
Success rate
Time frame: 1 day
Success rate of IO cannulation was defined as successful administration of infusion solutions via the performed IO access. Failure was defined as extravasation or unsuccessful (first) effort of IO insertion.
3 secondary outcomes
Time of IO insertion
Time frame: 1 day
Ease-of-use
Time frame: 1 day
first location
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 17 Mar 2016.
- Derived from this study: PubMed 27196493Szarpak L, Truszewski Z, Smereka J, Krajewski P, Fudalej M, Adamczyk P, Czyzewski L. A Randomized Cadaver Study Comparing First-Attempt Success Between Tibial and Humeral Intraosseous Insertions Using NIO Device by Paramedics: A Preliminary Investigation. Medicine (Baltimore). 2016 May;95(20):e3724. doi: 10.1097/MD.0000000000003724.
- Individual participant dataSharing planned: Undecided
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.
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 in people with Intraosseous Access and Resuscitation, run by Medical University of Warsaw 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 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: finished, as of the sponsor's last update on 17 Mar 2016. 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?
Success rate (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02700867, which also lists 1 linked publication.
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 17 Mar 2016; AzTrials last refreshed its copy on 27 Oct 2026.