UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039477 |
|---|---|
| Receipt number | R000041147 |
| Scientific Title | Examination of hypoxemia prevention effect of nasal high flow system for pediatric dental patients under intravenous sedation |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2020/06/12 19:12:26 |
* 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
Examination of hypoxemia prevention effect of nasal high flow system for pediatric dental patients under intravenous sedation
Acronym
Prevention of hypoxemia for pediatric patients under intravenous sedation
Scientific Title
Examination of hypoxemia prevention effect of nasal high flow system for pediatric dental patients under intravenous sedation
Scientific Title:Acronym
Prevention of hypoxemia for pediatric patients under intravenous sedation
Region
| Japan |
Condition
Condition
Dental phobia
Classification by specialty
| Dental medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of nasal high flow system in dental treatment under intravenous sedation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
intraoperative oxgen saturation
Key secondary outcomes
times of jaw elevation, postoperative expiratory carbon dioxide partial pressure, heart rate, blood pressure, respiratory rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
administration of high flow oxygen
Interventions/Control_2
administration of low flow oxygen
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
| 2 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy children who are uncooperate to dental treatment and scheduled for dental treatment under intravenous sedation
Key exclusion criteria
Children with systemic complications
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Teppei |
| Middle name | |
| Last name | Sago |
Organization
Kyushu Dental University
Division name
Division of Dental Anesthesiology
Zip code
803-8580
Address
2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka
TEL
093-582-1131
r07sagou@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Sago |
Organization
Kyushu Dental University
Division name
Division of Dental Anesthesiology
Zip code
803-8580
Address
2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka
TEL
093-582-1131
Homepage URL
r07sagou@fa.kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental University
Institute
Department
Personal name
Funding Source
Organization
Kyushu Dental University
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
The ethics committee of Kyushu Dental University
Address
2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka
Tel
093-582-1131
j06kawase@fa.kyu-dent.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
| 2020 | Year | 03 | Month | 01 | 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
| 2019 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 15 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 22 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 13 | Day |
Last modified on
| 2020 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041147
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
