NCT02275520

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

4 months

First QC Date

October 22, 2014

Last Update Submit

May 11, 2015

Conditions

Intraosseus AccessManikinResuscitation

Outcome Measures

Primary Outcomes (1)

  • time to IO needle insertion

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

    1 day

Secondary Outcomes (3)

  • time to IO needle stabilization

    1 day

  • time to intraosseuss infusion

    1 day

  • Ease of use

    1 day

Study Arms (1)

IO access

OTHER

Performed intraosseus access device during simulated cardiopulmonary resuscitation

Device: NIO Adult deviceDevice: Bone Iniection GunDevice: EZ-IODevice: Jamshidi Intraosseous NeedleDevice: Cook Intraosseous Needle

Interventions

NIO Adult deviceDEVICE

IO access-1

Also known as: NIO
IO access
Bone Iniection GunDEVICE

IO access-2

Also known as: BIG
IO access
EZ-IODEVICE

IO access-3

IO access
Jamshidi Intraosseous NeedleDEVICE

IO access-4

Also known as: Jamshidi
IO access
Cook Intraosseous NeedleDEVICE

IO access-5

Also known as: Cook
IO access

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Institute of Rescue Research and Education

Warsaw, Masovia, 03-122, Poland

Location

Study Officials

  • Lukasz Szarpak

    National Institute of Cardiology, Warsaw, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lukasz Szarpak

Study Record Dates

First Submitted

October 22, 2014

First Posted

October 27, 2014

Study Start

December 1, 2014

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

May 13, 2015

Record last verified: 2015-05

Locations

PL(1)