UMIN-CTR Clinical Trial

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
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	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
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	The ethics committee of Kyushu Dental University
Address	2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka
Tel	093-582-1131
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025680