UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024798 |
|---|---|
| Receipt number | 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 | 2019/12/11 16:32:25 |
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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
| Not applicable |
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 | Eiji |
| Middle name | |
| Last name | Sakamoto |
Organization
Kyushu University Faculty of Dental Science
Division name
Dental Anesthesiology
Zip code
8128485
Address
Maidashi 3-1-1 Higashiku Fukuoka, Fukuoka JAPAN
TEL
092-642-6478
esakamto@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Sakamoto |
Organization
Kyushu University Faculty of Dental Science
Division name
Dental Anesthesiology
Zip code
8128485
Address
Maidashi 3-1-1 Higashiku Fukuoka, Fukuoka JAPAN
TEL
092-642-6478
Homepage URL
esakamto@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Dental Anesthesiology
Kyushu University Faculty of Dental Science
Institute
Department
Personal name
Funding Source
Organization
Department of Dental Anesthesiology
Kyushu University Faculty of Dental Science
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
Department of Dental Anesthesiology Kyushu University Faculty of Dental Science
Address
Maidashi 3-1-1 Higashiku Fukuoka, Fukuoka JAPAN
Tel
092-642-6478
esakamto@dent.kyushu-u.ac.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
九州大学病院(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
| 2015 | Year | 12 | Month | 01 | Day |
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
| 2019 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028534
| 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 |
