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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000024798
Receipt No. R000028534
Scientific Title The evaluation of the prediction factors for perioperative respiratory adverse effects in pediatric anesthesia for the dental procedures
Date of disclosure of the study information 2016/11/11
Last modified on 2016/11/11

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Basic information
Public title The evaluation of the prediction factors for perioperative respiratory adverse effects in pediatric anesthesia for the dental procedures
Acronym The evaluation of the prediction factors for perioperative respiratory adverse effects
Scientific Title The evaluation of the prediction factors for perioperative respiratory adverse effects in pediatric anesthesia for the dental procedures
Scientific Title:Acronym The evaluation of the prediction factors for perioperative respiratory adverse effects
Region
Japan

Condition
Condition Anesthesia Dental procedures
Classification by specialty
Anesthesiology Oral surgery Dental medicine
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate prediction factors with perioperative respiratory adverse effects in pediatric anesthesia
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Incidents of the perioperative respiratory adverse effects
Key secondary outcomes

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
10 years-old >=
Gender Male and Female
Key inclusion criteria General anesthesia within six hours cases of dental procedures and oral surgery from o to ten years old .
Key exclusion criteria over six hors and / or eleven years old
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Sakamoto
Organization Kyushu University
Division name Dental Anesthesiology
Zip code
Address Maidashi 3-1-1 Higashiku Fukuoka, Fukuoka JAPAN
TEL 092-642-6780
Email esakamto@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Sakamoto
Organization Kyushu University
Division name Dental Anesthesiology
Zip code
Address Maidashi 3-1-1 Higashiku Fukuoka, Fukuoka JAPAN
TEL 092-642-6780
Homepage URL
Email esakamto@dent.kyushu-u.ac.jp

Sponsor
Institute Department of Dental Anesthesiology Kyushu University
Institute
Department

Funding Source
Organization Department of Dental Anesthesiology Kyushu University
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JAPAN

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 九州大学病院 歯科麻酔科(福岡)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 11 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 Main results already published
Date of protocol fixation
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 01 Day
Last follow-up date
2020 Year 11 Month 30 Day
Date of closure to data entry
2020 Year 11 Month 30 Day
Date trial data considered complete
2020 Year 11 Month 30 Day
Date analysis concluded
2020 Year 11 Month 30 Day

Other
Other related information Retrospective observational study

Management information
Registered date
2016 Year 11 Month 11 Day
Last modified on
2016 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028534

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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