UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038375 |
|---|---|
| Receipt number | R000042795 |
| Scientific Title | Perioperative management of CPAP in pediatric obestuctive sleep apnea. |
| Date of disclosure of the study information | 2019/10/24 |
| Last modified on | 2023/04/27 12:50:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Perioperative management of CPAP in pediatric obestuctive sleep apnea.
Acronym
Perioperative management of CPAP in children.
Scientific Title
Perioperative management of CPAP in pediatric obestuctive sleep apnea.
Scientific Title:Acronym
Perioperative management of CPAP in children.
Region
| Japan |
Condition
Condition
obstructive sleep apnea
Classification by specialty
| Pediatrics | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of perioperative continuous positive airway pressure in pediatric obstructive sleep apnea.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Operation time, anesthesia time, amount of bleeding in operation, post-operative desaturation and post-operative pain.
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
| 3 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Obstructive sleep apnea as apnea hypopnea index (AHI) > 20 /hr diagnosed with polysomnography.
Key exclusion criteria
Maxillo facial malformation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Inoshita |
Organization
Juntendo Hospital
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
ayaent@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Inoshita |
Organization
Juntendo Hospital
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
ayaent@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo Hospital
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
kenkyu5858@juntendo.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2019 | Year | 10 | Month | 24 | Day |
Last modified on
| 2023 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042795
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
