UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010740 |
|---|---|
| Receipt number | R000012551 |
| Scientific Title | Comparison of pediatric intubation device using cervical immobilized simulator during chest compression |
| Date of disclosure of the study information | 2013/05/16 |
| Last modified on | 2013/05/16 12:40:32 |
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Basic information
Public title
Comparison of pediatric intubation device using cervical immobilized simulator during chest compression
Acronym
Comparison of pediatric intubation device using cervical immobilized simulator during chest compression
Scientific Title
Comparison of pediatric intubation device using cervical immobilized simulator during chest compression
Scientific Title:Acronym
Comparison of pediatric intubation device using cervical immobilized simulator during chest compression
Region
| Japan |
Condition
Condition
cardiac arrest due to trauma
Classification by specialty
| Pediatrics | Anesthesiology | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare time to intubation with video-laryngoscope, AirwayScope (AS) (Hoya, Tokyo, Japan) in a simulated trauma child with cervical spine immobilization during chest compression with that with conventional laryngoscope (CL) at 6 weeks after watching brief standardized instruction video for each.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
time to intubation 6 weeks after the interventions, in a simulated cardiac arrest child with cervical spine immobilization
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
standardized instruction video for AirwayScope
Interventions/Control_2
standardized instruction video for conventional laryngoscope
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
non-anesthesia physician at Tokyo Metropolitan Children's Medical Center
Key exclusion criteria
1. those who don't agree
2. those who will move to other hospitals within 6 weeks
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanari Ikeyama |
Organization
Tokyo Metropolitan Children's Medical Center, Japan
Division name
Department of Pediatric Emergency and Critical Care Medicine
Zip code
Address
2-8-29 Musashidai, Fuchu, Tokyo JAPAN zip 183-8561
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Metropolitan Children's Medical Center, Japan
Division name
Department of Pediatric Emergency and Critical Care Medicine
Zip code
Address
TEL
Homepage URL
http://www.byouin.metro.tokyo.jp/shouni/tiken/koukaigenkou/24-48doctor.pdf
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center, Japan
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Children's Medical Center, Japan
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
| 2013 | Year | 05 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 02 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 02 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 10 | Day |
Date analysis concluded
| 2013 | Year | 05 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 16 | Day |
Last modified on
| 2013 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012551
