UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison between conventional nasal intubation and Rhinoscope-guided nasotracheal intubation
Title of the study (Brief title)	Comparison between conventional nasal intubation and Rhinoscope-guided nasotracheal intubation
Region	Japan

Condition
Condition	Patients scheduled to undergo elective surgery requireing asleep nasotracheal intubation
Classification by specialty	Anesthesiology Oral surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Performing different methods of nasal intubation, we will compare whether there will be a difference in nasal bleeding or postoperative sore throat.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Degree of nasal bleeding Degree of sore throat Degree of resistance in nasal passage
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	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Rhinoscope-guided nasotracheal intubation
Interventions/Control_2	Blind nasal passage without any device.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	Patients undergoing general anesthesia
Key exclusion criteria	bleeding disorder abnormal nasal cavity
Target sample size	100

Research contact person
Name of lead principal investigator	Chiaki Nemoto
Organization	Ohara general hospital
Division name	Department of anesthesiology
Address	6-1 Uwamachi Fukushima-city Fukushima
TEL	024-526-0300
Email	hippo_hipp0@yahoo.co.jp

Public contact
Name of contact person	Midori Mogami
Organization	Ohara general hospital
Division name	Department of anesthesiology
Address	6-1 Uwamachi Fukushima-city Fukushima
TEL	024-526-0300
Homepage URL
Email	contralt.inutaro@gmail.com

Sponsor
Institute	Ohara general hospital
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)

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	2019 Year 03 Month 07 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2019 Year 03 Month 07 Day
Anticipated trial start date	2019 Year 03 Month 07 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	2019 Year 03 Month 07 Day
Last modified on	2019 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041148