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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011480
Receipt No. R000013436
Scientific Title Standardization of Management during Pediatric Sedation for MRI : A Prospective Observational Study
Date of disclosure of the study information 2013/08/14
Last modified on 2015/02/16

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Basic information
Public title Standardization of Management during Pediatric Sedation for MRI
: A Prospective Observational Study
Acronym Standardization of Management during Pediatric Sedation for MRI
Scientific Title Standardization of Management during Pediatric Sedation for MRI
: A Prospective Observational Study
Scientific Title:Acronym Standardization of Management during Pediatric Sedation for MRI
Region
Japan

Condition
Condition Infants and children who need sedation for MRI
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the efficacy of our protocol, which includes well-designed sedation regimes using oral triclofos sodium or rectal chloral hydrate and intravenous midazolam offered with risk management plans. Thereby, we are going to establish standardized sedation regimes and risk management systems including monitoring during pediatric sedation for MRI
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The rate of successful sedation, which defined the number of successful sedation cases divided by all cases.
Criteria of the successful sedation
Little of no motion artifacts on the images judged by radiologists.
Completion of MRI within the maximum dosage of the sedative protocol.
Key secondary outcomes The rate of successful sedation during the length of normal MRI examination, which we set 40 minutes.
Adverse events during sedation.
Dosages of sedatives, time from the administration of sedatives until the completion of the adequate sedation, the time to return to the normal state of awareness.
The delay of the start of MRI from the scheduled time.
The rate of acceptable images, which defined the number of acceptable sequences divided by the number of all sequences.
Possible correlation between successful sedation and patient characteristics

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
0 years-old <=
Age-upper limit
6 years-old >
Gender Male and Female
Key inclusion criteria Patients who require sedation for MRI judged by their doctors.
Informed written consent from the legal representatives for the participation of the study.
Key exclusion criteria 1 Class3 or 4 in ASA-Physical status
2 Class3 or 4 in Mallampaticlassification
3 Patients who have underlying disease with airway abnormality.
4 Patients with acute respiratory infection
5 Patients with known allergy to benzodiazepines or flumazenil
6 Patients on regular benzodiazepines
7 Previous participation of the study.
8 Patients who are assessed inappropriate for the study judged by the doctor in charge.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihiro Hasegawa
Organization Tokyo Metropolitan Childrens' Medical Center
Division name General Medicine
Zip code
Address 2-8-29,Musashidai,Fuchu-city,Tokyo Metropolice,183-8561,JAPAN
TEL 042-300-5111
Email yukihiro_hasegawa@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuto Takahashi
Organization Tokyo Metropolitan Childrens' Medical Center
Division name General Medicine
Zip code
Address 2-8-29,Musashidai,Fuchu-city,Tokyo Metropolice,183-8561,JAPAN
TEL 042-300-5111
Homepage URL http://www.byouin.metro.tokyo.jp/shouni/tiken/index_rinshoukenkyu.html
Email takuto_takahashi@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Childrens' Medical Center
Institute
Department

Funding Source
Organization Tokyo Metropolitan Childrens' Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 東京都立小児総合医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 14 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
2013 Year 06 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 02 Day
Last follow-up date
2014 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2013 Year 08 Month 13 Day
Last modified on
2015 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013436

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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