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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022939
Receipt No. 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 2017/01/06

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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
Middle name
Last name Teppei Sago
Organization Kyushu Dental University
Division name Department of dental anesthesiology
Zip code
Address 2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka 803-8580 JAPAN
TEL 093-582-1131
Email r07sagou@fa.kyu-dent.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teppei Sago
Organization Kyushu Dental University
Division name Department of dental anesthesiology
Zip code
Address 2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka 803-8580 JAPAN
TEL 093-582-1131
Homepage URL
Email r07sagou@fa.kyu-dent.ac.jp

Sponsor
Institute Kyushu Dental University
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2016 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
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
2017 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025680

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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