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Intraosseous Access During Pediatric Resuscitation (IOCPR)

Primary Purpose

Cardiac Arrest

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Peripheral venous catheterization
Jamshidi
BIG
Cook
EZIO
Sponsored by
International Institute of Rescue Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Catheterization, Peripheral

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • give voluntary consent to participate in the study
  • minimum 1 year of work experience in emergency medicine
  • experienced emergency medical personnel - EMS-paramedics

Exclusion Criteria:

  • not meet the above criteria
  • wrist or low back diseases

Sites / Locations

  • International Institute of Rescue Research and EducationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Peripheral venous catheterization

intraosseous access

Arm Description

Peripheral venous catheterization during pediatric resuscitation

Intraosseus access using intraosseous access devices during resuscitation

Outcomes

Primary Outcome Measures

Success rate on first attempt

Secondary Outcome Measures

Ease of use
Ease of use as reported by participants
Time to successfully perform
Time to successfully perform the intraosseous access

Full Information

First Posted
November 27, 2014
Last Updated
December 1, 2014
Sponsor
International Institute of Rescue Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT02305511
Brief Title
Intraosseous Access During Pediatric Resuscitation
Acronym
IOCPR
Official Title
A Comparison of Four Intraosseous Access Devices With Standard Venous Catheterization During Child Cardiopulmonary Resuscitation Simulation: a Randomized Crossover Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Institute of Rescue Research and Education

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to compare the Jamshidi, the BIG, the Cook, the EZIO intraosseous devices to standard peripheral venous catheterization during pediatric resuscitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Catheterization, Peripheral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peripheral venous catheterization
Arm Type
Experimental
Arm Description
Peripheral venous catheterization during pediatric resuscitation
Arm Title
intraosseous access
Arm Type
Experimental
Arm Description
Intraosseus access using intraosseous access devices during resuscitation
Intervention Type
Device
Intervention Name(s)
Peripheral venous catheterization
Intervention Description
Cannulation using standard method
Intervention Type
Device
Intervention Name(s)
Jamshidi
Intervention Description
intraosseous access using the Jamshidi device
Intervention Type
Device
Intervention Name(s)
BIG
Other Intervention Name(s)
Bone Injection Gun
Intervention Description
intraosseous access using the BIG device
Intervention Type
Device
Intervention Name(s)
Cook
Intervention Description
intraosseous access using the Cook device
Intervention Type
Device
Intervention Name(s)
EZIO
Intervention Description
intraosseous access using the EZIO device
Primary Outcome Measure Information:
Title
Success rate on first attempt
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Ease of use
Description
Ease of use as reported by participants
Time Frame
1 day
Title
Time to successfully perform
Description
Time to successfully perform the intraosseous access
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: give voluntary consent to participate in the study minimum 1 year of work experience in emergency medicine experienced emergency medical personnel - EMS-paramedics Exclusion Criteria: not meet the above criteria wrist or low back diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrzej Kurowski
Phone
+48500186225
Email
andrzejkurowski987@gmail.com
Facility Information:
Facility Name
International Institute of Rescue Research and Education
City
Warsaw
State/Province
Masovia
ZIP/Postal Code
03-122
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
Phone
+48500186225
Email
lukasz.szarpak@gmail.com
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
First Name & Middle Initial & Last Name & Degree
Andrzej Kurowski
First Name & Middle Initial & Last Name & Degree
Lukasz Czyżewski

12. IPD Sharing Statement

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Intraosseous Access During Pediatric Resuscitation

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