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Trial Comparing Proximal Tibia and Proximal Humerus Infusion Rates Using the NIO Intraosseous Device

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02700867
Acronym
IOACS
Enrollment
84
Registered
2016-03-07
Start date
2016-02-29
Completion date
2016-03-31
Last updated
2016-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraosseous Access, Resuscitation

Keywords

intraosseous access, cardiopulmonary resuscitation, paramedic, simulation, cadaver

Brief 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.

Interventions

DEVICENIO

Intraosseous access device NIO (Defibtech)

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* give voluntary consent to participate in the study * paramedics * without previous experience in intraosseous devices

Exclusion criteria

* not meet the above criteria

Design outcomes

Primary

MeasureTime frameDescription
Success rate1 daySuccess 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.

Secondary

MeasureTime frameDescription
first location1 dayParticipants were asked to record their first location access tibia or humerus
Time of IO insertion1 dayProcedure 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.
Ease-of-use1 dayease-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).

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026