CClinicalTrials.gg
CompletedNCT02275520NIOUpdated May 13, 2015

Intraosseous Access

An interventional study of NIO Adult device and Bone Iniection Gun in Intraosseus Access, Manikin and Resuscitation, sponsored by International Institute of Rescue Research and Education. Completed at 1 site in Poland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-13.

Sponsored by International Institute of Rescue Research and Education · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
137
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The investigators will compare the success rates and time to successful IO access during simulated adult resuscitation.

02

Conditions studied

  • Intraosseus Access
  • Manikin
  • Resuscitation
03

In context

Lead sponsor

International Institute of Rescue Research and Education is the lead sponsor of 36 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Give voluntary consent to participate in the study
  • paramedic
  • more than 1 year experience in medicine

Exclusion criteria

Exclusion Criteria:

  • Not meet the above criteria
  • Wrist or Low back diseases
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
137 participants (actual)

Study arms

  • Other
    IO access

    Performed intraosseus access device during simulated cardiopulmonary resuscitation

    Device: NIO Adult device · Device: Bone Iniection Gun · Device: EZ-IO · Device: Jamshidi Intraosseous Needle · Device: Cook Intraosseous Needle

Interventions

  • DeviceNIO Adult device

    IO access-1

    Also known as: NIO

  • DeviceBone Iniection Gun

    IO access-2

    Also known as: BIG

  • DeviceEZ-IO

    IO access-3

  • DeviceJamshidi Intraosseous Needle

    IO access-4

    Also known as: Jamshidi

  • DeviceCook Intraosseous Needle

    IO access-5

    Also known as: Cook

06

What researchers measure

Primary outcomes

  1. time to IO needle insertion

    time from picking up a intraosseous access device, to successful IO needle insertion in the bone

    Time frame: 1 day

Secondary outcomes

  1. time to IO needle stabilization

    time from picking up a intraosseus access device to correct fixation IO needle

    Time frame: 1 day

  2. 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

    Time frame: 1 day

  3. 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).

    Time frame: 1 day

07

Study locations

1 site
  • International Institute of Rescue Research and Education
    Warsaw, Masovia 03-122, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02275520
Lead sponsor
International Institute of Rescue Research and Education
Responsible party
Lukasz Szarpak (Lukasz Szarpak, National Institute of Cardiology, Warsaw, Poland) — Principal investigator
First posted
Oct 27, 2014
Start date
Dec 2014
Primary completion
Apr 2015
Completion
May 2015
Last update
May 13, 2015

Study contacts

Lukasz Szarpak
principal investigator · National Institute of Cardiology, Warsaw, Poland

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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