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

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 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

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

Value
https://center6.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