UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039477
Receipt No. 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

* 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
Email 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
Email r07sagou@fa.kyu-dent.ac.jp

Sponsor
Institute Kyushu Dental University
Institute
Department

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
Email 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
URL(English) https://upload.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


Contact us.