UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033043 |
|---|---|
| Receipt number | R000037668 |
| Scientific Title | A randamized multicenter trial to evaluate the respiration-linked application game system for supporting pediatric anesthesia induction. |
| Date of disclosure of the study information | 2018/06/18 |
| Last modified on | 2019/04/15 06:19:58 |
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Basic information
Public title
A randamized multicenter trial to evaluate the respiration-linked application game system for supporting pediatric anesthesia induction.
Acronym
A randamized multicenter trial to evaluate the respiration-linked application game system for supporting pediatric anesthesia induction.
Scientific Title
A randamized multicenter trial to evaluate the respiration-linked application game system for supporting pediatric anesthesia induction.
Scientific Title:Acronym
A randamized multicenter trial to evaluate the respiration-linked application game system for supporting pediatric anesthesia induction.
Region
| Japan |
Condition
Condition
children who are supposed to receive inhalational induction of general anesthesia
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that the respiration-linked game system reduces the incidence of stormy induction in pediatric patients.
Basic objectives2
Others
Basic objectives -Others
To analyze exploratorily the factors affecting the incidence of stormy induction.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of stormy induction defined as anesthesia induction with initial sevoflurane concentration greater than 5% and application of physical restraint to the child refusing anesthesia mask.
Key secondary outcomes
Anxiety level (mYPAS: modified Yale preoperative anxiety scale), Time required for the patient to accept the anesthesia mask, Satisfaction level of the parents.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group; Make children to use the respiration-linked tablet game system during the inhalational induction of general anesthesia.
Interventions/Control_2
Control group; inhalational induction of general anesthesia with routine procedure (without the respiration-linked tablet game system).
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
| 1 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Child who is supposed to receive inhalational induction of general anesthesia for their elective surgery, American Society of Anesthesiologists physical status 1 or 2
Key exclusion criteria
Patients with any experience of general anesthesia, mental retardation, or neuromuscular disease
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Kitamura |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-222-7171
ujkitasan@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Kitamura |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-222-7171
Homepage URL
ujkitasan@yahoo.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
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
千葉大学医学部附属病院（千葉県）、宮城県立こども病院（宮城県）、松戸市立総合医療センター（千葉県）、あいち小児保健医療総合センター（愛知県）、聖マリア病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 18 | 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
| 2018 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 18 | Day |
Last modified on
| 2019 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037668
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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