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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033043
Receipt No. 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

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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
Email 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
Email ujkitasan@yahoo.co.jp

Sponsor
Institute Chiba University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037668

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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