UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Microbiological study on nasotracheal intubation
Title of the study (Brief title)	Microbiological study on nasotracheal intubation
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will clarify which disinfectant should be used for hygienic nasotracheal intubation.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of bacteria after disinfection
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Use povidone-iodine as a disinfectant
Interventions/Control_2	Use benzalkonium chloride as a disinfectant
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	18 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy Adults
Key exclusion criteria	Patient with allergy of povidone-iodine or benzalkonium chloride
Target sample size	50

Research contact person
Name of lead principal investigator	Jun Harada
Organization	Aichi Gakuin University School of Dentistry
Division name	Department of Anesthesiology
Address	2-11 Suemoridori, Chikusa-ku, Nagoya, Aichi, 464-8651, Japan
TEL	052-759-2111
Email	hjun@dpc.agu.ac.jp

Public contact
Name of contact person	Aiji Sato(Boku)
Organization	Aichi Gakuin University School of Dentistry
Division name	Department of Anesthesiology
Address	2-11 Suemoridori, Chikusa-ku, Nagoya, Aichi, 464-8651, Japan
TEL	052-759-2111
Homepage URL
Email	bokuaiji@dpc.agu.ac.jp

Sponsor
Institute	Aichi Gakuin University School of Dentistry
Institute
Department

Funding Source
Organization	Aichi Gakuin University School of Dentistry
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	愛知学院大学歯学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 18 Day
Anticipated trial start date	2017 Year 10 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 21 Day
Last modified on	2018 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033873