Intraosseous Access (NIO)

May 11, 2015 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: IO access
Performed intraosseus access device during simulated cardiopulmonary resuscitation
Device: NIO Adult device
IO access-1
Other Names:
  • NIO
Device: Bone Iniection Gun
IO access-2
Other Names:
  • BIG
Device: EZ-IO
IO access-3
Device: Jamshidi Intraosseous Needle
IO access-4
Other Names:
  • Jamshidi
Device: Cook Intraosseous Needle
IO access-5
Other Names:
  • Cook

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to IO needle stabilization
Time Frame: 1 day
time from picking up a intraosseus access device to correct fixation IO needle
1 day
time to intraosseuss infusion
Time Frame: 1 day
begining with picking up a intraosseuss access device and ending with the IV line tubing was connected to the inseted IO needle
1 day
Ease of use
Time Frame: 1 day
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).
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Institute of Rescue Research and Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

October 24, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • IO2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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