UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019695 |
|---|---|
| Receipt number | R000020995 |
| Scientific Title | The Change of Pulse Rate and Behavioral Score by Using Video Assisted Induction of Pediatric Anesthesia |
| Date of disclosure of the study information | 2015/11/09 |
| Last modified on | 2021/08/25 15:55:10 |
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Basic information
Public title
The Change of Pulse Rate and Behavioral Score by Using Video Assisted Induction of Pediatric Anesthesia
Acronym
The effect of video assisted induction of pediatric anesthesia
Scientific Title
The Change of Pulse Rate and Behavioral Score by Using Video Assisted Induction of Pediatric Anesthesia
Scientific Title:Acronym
The effect of video assisted induction of pediatric anesthesia
Region
| Japan |
Condition
Condition
pediatric surgery,plastic surgery, the infant urology department
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was whether the video assisted anesthesia induction reduces the pediatric patients stress to indicate the decreasing of pulse rate and behavioral score.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) the pulse rate at four points (the ward, the entrance of operating room, look at the mask and fit the mask)
(2) the behavioral score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Video assisted induction of anesthesia
Interventions/Control_2
No video assisted induction of anesthesia
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
| 2 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
randomaized
Key exclusion criteria
Exclusion criteria included patients having mental retardation, development delay and receiving several operations.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ozaki |
Organization
Tokyo Women's Medical University
Division name
Department of anesthesia
Zip code
1628666
Address
8-1 Kawadachou Shinjyukuku Tokyo Japan
TEL
03-3353-8111
mozaki@anes.twmu.ac.jp
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Abukawa |
Organization
Tokyo Women's Medical University
Division name
Department of anesthesia
Zip code
1628666
Address
8-1 Kawadachou Shinjyukuku Tokyo Japan
TEL
03-3353-8111
Homepage URL
yukako1@rg8.so-net.ne.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University
Address
Kawadachou Shinjyukuku Tokyo Japan
Tel
0333431111
yukakoabukawasandy@yahoo.co.jp
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
| 2015 | Year | 11 | Month | 09 | 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
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 09 | Day |
Last modified on
| 2021 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020995
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
