UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of Semi-automatic Intraosseous Device (EZ-IO) as Reported by Pediatric Nurses and Physicians: A Comparison
Title of the study (Brief title)	Utility of Semi-automatic Intraosseous Device (EZ-IO) as Reported by Pediatric Nurses and Physicians: A Comparison
Region	Japan

Condition
Condition	resuscitation
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the difficulty scale, time to deployment, and success rate in EZ-IO use between pediatric nurses and physicians.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mean difficulty rate
Key secondary outcomes	Time to deployment and success rate

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Each pediatric nurse was individually trained by the study investigator correctly to deploy the EZ-IO. They were then asked to try inserting a needle into the tibia of an infant training model.
Interventions/Control_2	Each pediatric physician was individually trained by the study investigator correctly to deploy the EZ-IO. They were then asked to try inserting a needle into the tibia of an infant training model.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Medical personnel who had never used the EZ-IO
Key exclusion criteria	Medical personnel who had ever used the EZ-IO
Target sample size	60

Research contact person
Name of lead principal investigator	Motoki Yasuda
Organization	Tokyo Metropolitan Children's Medical Centor
Division name	Division of Pediatric Emergency Medicine
Address	2-8-29, Musashidai, Fuchu, Tokyo, Japan
TEL	042-300-5111
Email	fi000168@yahoo.co.jp

Public contact
Name of contact person	Motoki Yasuda
Organization	Tokyo Metropolitan Children's Medical Centor
Division name	Division of Pediatric Emergency Medicine
Address	2-8-29, Musashidai, Fuchu, Tokyo, Japan
TEL	042-300-5111
Homepage URL
Email	fi000168@yahoo.co.jp

Sponsor
Institute	Division of Pediatric Emergency Medicine, Tokyo Metropolitan Children's Medical Centor
Institute
Department

Funding Source
Organization	Others
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 20 Day
Anticipated trial start date	2016 Year 06 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 23 Day
Last modified on	2016 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027793