UMIN-CTR Clinical Trial

Basic information
Public title	Examination of airway management method in intravenous anesthesia using Nasal High Flow load device AIRVO
Acronym	Examination of airway management method in intravenous anesthesia using Nasal High Flow
Scientific Title	Examination of airway management method in intravenous anesthesia using Nasal High
Scientific Title:Acronym	Examination of airway management method in intravenous anesthesia using Nasal High Flow
Region	Japan

Condition
Condition	intravenous anesthesia
Classification by specialty	Anesthesiology Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Elucidate how Nasal High Flow high-flow air load device improves respiratory function and how salivary swallowing function is affected by upper airway obstruction during intravenous anesthesia
Basic objectives2	Others
Basic objectives -Others	The Nasal High Flow loading device, which flows air at a high flow rate from the nasal cavity, has been reported to improve respiratory function during intravenous anesthesia due to mild positive pressure load (several cmH2O) and decreased rebreathing. It is also starting to be applied to management. However, there are no studies that have examined the effectiveness of Nasal High Flow for upper airway obstruction during anesthesia, and it is not clear how it affects salivary swallowing function. In this study, we will elucidate the mechanism by which a high-flow air load device improves upper airway obstruction that occurs during anesthesia and during anesthesia awakening, and how much the salivary swallowing function is affected.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Upper airway patency
Key secondary outcomes	Saliva swallowing function

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	propofol
Interventions/Control_2	Dexmedetomidine
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	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	Targeting healthy adult subjects (volunteers) who agree with the explanation of the contents of the research plan.
Key exclusion criteria	1) Patients with severe respiratory illness 2) Patients with serious cardiovascular disease 3) Diabetes patients with poor control 4) Severe kidney injury patients 5) Patients with severe liver damage 6) Patients with hypersensitivity (allergy) to the drug to be used 7) Patients who are judged inappropriate by the research supervisor or research supervisor
Target sample size	50

Research contact person
Name of lead principal investigator	1st name TAKAO Middle name Last name AYUSE
Organization	Nagasaki University
Division name	Dental Anesthesia
Zip code	8528588
Address	1-7-1 Sakamoto Nagasaki
TEL	0958197713
Email	ayuse@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name TAKAO Middle name Last name AYUSE
Organization	Nagasaki University Hospital
Division name	Dental Anesthesia
Zip code	8528588
Address	1-7-1 Sakamoto Nagasaki
TEL	0958197713
Homepage URL
Email	ayuse@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Nagasaki Universuty
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	Nagasaki University Graduate School of Biomedical Sciences (Dental Science) Ethics Committee
Address	1-7-1 Sakamoto Nagasaki
Tel	0958197177
Email	ayuse@nagasaki-u.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

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 09 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	Enrolling by invitation
Date of protocol fixation	2019 Year 03 Month 09 Day
Date of IRB	2019 Year 03 Month 09 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 04 Month 30 Day
Date trial data considered complete	2022 Year 05 Month 30 Day
Date analysis concluded	2022 Year 06 Month 15 Day

Other
Other related information

Management information
Registered date	2019 Year 09 Month 27 Day
Last modified on	2021 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043453