UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024138 |
|---|---|
| Receipt number | R000027793 |
| Scientific Title | Utility of Semi-automatic Intraosseous Device (EZ-IO) as Reported by Pediatric Nurses and Physicians: A Comparison |
| Date of disclosure of the study information | 2016/09/23 |
| Last modified on | 2016/09/28 10:02:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Utility of Semi-automatic Intraosseous Device (EZ-IO) as Reported by Pediatric Nurses and Physicians: A Comparison
Acronym
Utility of Semi-automatic Intraosseous Device (EZ-IO) as Reported by Pediatric Nurses and Physicians: A Comparison
Scientific Title
Utility of Semi-automatic Intraosseous Device (EZ-IO) as Reported by Pediatric Nurses and Physicians: A Comparison
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Motoki Yasuda |
Organization
Tokyo Metropolitan Children's Medical Centor
Division name
Division of Pediatric Emergency Medicine
Zip code
Address
2-8-29, Musashidai, Fuchu, Tokyo, Japan
TEL
042-300-5111
fi000168@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoki Yasuda |
Organization
Tokyo Metropolitan Children's Medical Centor
Division name
Division of Pediatric Emergency Medicine
Zip code
Address
2-8-29, Musashidai, Fuchu, Tokyo, Japan
TEL
042-300-5111
Homepage URL
fi000168@yahoo.co.jp
Sponsor or person
Institute
Division of Pediatric Emergency Medicine, Tokyo Metropolitan Children's Medical Centor
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 20 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027793
