Intraosseous Access During Pediatric Resuscitation | NCT02305511

Studies
Intraosseous Access During Pediatric Resuscitation

NCT02305511

Sponsor

International Institute of Rescue Research and Education

Status

Unknown status

Last Update Posted

Dec 2, 2014Estimated

Enrollment

130Estimated

Phase

Not Applicable

Conditions

Cardiac Arrest

Interventions

Peripheral venous catheterization
Jamshidi
BIG
Cook
EZIO

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Nov 27, 2014

First Submission Date that Met QC Criteria

Dec 1, 2014

First Posted Date

Dec 2, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2014

Last Update Posted Date

Dec 2, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lukasz Szarpak, Lukasz Szarpak, National Institute of Cardiology, Warsaw, PolandPrincipal Investigator

Lead Sponsor

International Institute of Rescue Research and EducationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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: Jamshidi Device: BIG Device: Cook Device: EZIO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peripheral venous catheterization	Device	Cannulation using standard method	Peripheral venous catheterization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rate on first attempt		1 day

Secondary Outcomes

Measure	Description	Time Frame
Ease of use	Ease of use as reported by participants	1 day
Time to successfully perform	Time to successfully perform the intraosseous access

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrzej Kurowski	Contact	+48500186225		andrzejkurowski987@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
International Institute of Rescue Research and Education	Recruiting	Warsaw	Masovia	03-122	Poland

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002406	Catheterization, Peripheral

Ancestor Terms

ID	Term
D002404	Catheterization
D013812	Therapeutics
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided