Intraosseous Access

Resuscitation Clinical Trial

— NIO  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275520
• Other study ID #: IO2014
• Status: Completed
• Phase: N/A
• First received: October 22, 2014
• Last updated: May 11, 2015
• Start date: December 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: International Institute of Rescue Research and Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraosseus Access
• Manikin
• Resuscitation

Intervention

Device:
• NIO Adult device
IO access-1
• Bone Iniection Gun
IO access-2
• EZ-IO
IO access-3
• Jamshidi Intraosseous Needle
IO access-4
• Cook Intraosseous Needle
IO access-5

Locations

Country	Name	City	State
Poland	International Institute of Rescue Research and Education	Warsaw	Masovia

Sponsors (1)

Lead Sponsor	Collaborator
International Institute of Rescue Research and Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to IO needle insertion	time from picking up a intraosseous access device, to successful IO needle insertion in the bone	1 day	No
Secondary	time to IO needle stabilization	time from picking up a intraosseus access device to correct fixation IO needle	1 day	No
Secondary	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	1 day	No
Secondary	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).	1 day	No