UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022939 |
|---|---|
| Receipt number | R000025680 |
| Scientific Title | Preventive effect of a nasal high-flow system for hypoxia in pediatric dental patients under intravenous sedation. |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2020/02/13 19:59:36 |
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Basic information
Public title
Preventive effect of a nasal high-flow system for hypoxia in pediatric dental patients under intravenous sedation.
Acronym
Effects of a nasal high-flow system in pediatric dental patients under intravenous sedation.
Scientific Title
Preventive effect of a nasal high-flow system for hypoxia in pediatric dental patients under intravenous sedation.
Scientific Title:Acronym
Effects of a nasal high-flow system in pediatric dental patients under intravenous sedation.
Region
| Japan |
Condition
Condition
Dental phobia
Classification by specialty
| Anesthesiology | Dental medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intravenous sedation under dental treatment has been used as an effective method for the pediatric patients of dental phobia. However, if an attempt is made to obtain a valid sedation in case the treatment of pediatric patients, complications such as hypoxemia is likely to occur. The aim of this study is to show a preventive effect on these complications through a nasal high-flow system, to allow a safer intravenous sedation under dental treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Arterial oxygen partial pressure (at the end of surgery)
Key secondary outcomes
Arterial partial pressure of carbon dioxide (at the end of surgery)
Non-invasive arterial pressure (from the anesthesia start up to one hour after anesthesia end)
Arterial blood oxygen saturation (from anesthesia start up to one hour after anesthesia end)
Heart rate (from anesthesia start up to one hour after anesthesia end)
BIS value (from anesthesia start up to one hour after anesthesia end)
Intervention number of times (during surgery)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using nasal high-flow system under intravenous sedation
Interventions/Control_2
Using nasal cannula under intravenous sedation
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
Children with no systemic complications who are judged to be necessary for dental treatment under intravenous sedation
Key exclusion criteria
There are other complications besides dental disease
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
Department of dental anesthesiology
Zip code
803-8580
Address
2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka 803-8580 JAPAN
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
Department of dental anesthesiology
Zip code
803-8580
Address
2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka 803-8580 JAPAN
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
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
The ethics committee of Kyushu Dental University
Address
2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka
Tel
093-582-1131
r06kawase@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
九州歯科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 29 | Day |
Last modified on
| 2020 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025680
