NCT02305511

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2014

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

1 month

First QC Date

November 27, 2014

Last Update Submit

December 1, 2014

Conditions

Keywords

CatheterizationPeripheral

Outcome Measures

Primary Outcomes (1)

  • Success rate on first attempt

    1 day

Secondary Outcomes (2)

  • Ease of use

    1 day

  • Time to successfully perform

    1 day

Study Arms (2)

Peripheral venous catheterization

EXPERIMENTAL

Peripheral venous catheterization during pediatric resuscitation

Device: Peripheral venous catheterization

intraosseous access

EXPERIMENTAL

Intraosseus access using intraosseous access devices during resuscitation

Device: JamshidiDevice: BIGDevice: CookDevice: EZIO

Interventions

Cannulation using standard method

Peripheral venous catheterization
JamshidiDEVICE

intraosseous access using the Jamshidi device

intraosseous access
BIGDEVICE

intraosseous access using the BIG device

Also known as: Bone Injection Gun
intraosseous access
CookDEVICE

intraosseous access using the Cook device

intraosseous access
EZIODEVICE

intraosseous access using the EZIO device

intraosseous 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
  • minimum 1 year of work experience in emergency medicine
  • experienced emergency medical personnel - EMS-paramedics

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

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Interventions

Catheterization, Peripheral

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Central Study Contacts

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

November 27, 2014

First Posted

December 2, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations