UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the influence on the circulatory system by the airway management method using Nasal High Flow load device AIRVO during sedation
Acronym	Examination of the influence on the circulatory system by the airway management method using Nasal High Flow load device AIRVO during sedation
Scientific Title	Examination of the influence on the circulatory system by the airway management method using Nasal High Flow load device AIRVO during sedation
Scientific Title:Acronym	Examination of the influence on the circulatory system by the airway management method using Nasal High Flow load device AIRVO during sedation
Region	Japan

Condition
Condition	DENTISTRY
Classification by specialty	Anesthesiology Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate whether the application of NHF increases the intrathoracic pressure and decreases the afterload, and secondarily increases the cardiac output.
Basic objectives2	Others
Basic objectives -Others	The purpose of this study is to investigate whether the application of NHF increases the intrathoracic pressure and decreases the afterload, and secondarily increases the cardiac output.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Estimated afterload and cardiac output during waking and sedation
Key secondary outcomes	Tidal volume and respiratory rate during waking and sedation

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Twenty adult healthy volunteers (volunteers) who agreed with the explanation of the content of the research plan are targeted.
Key exclusion criteria	1) Patients with serious respiratory illness (asthma) 2) Patients with serious cardiovascular disease (congenital heart disease) 3) Uncontrolled diabetic patients 4) Patients with severe renal impairment 5) Patients with severe liver damage 6) Patients with hypersensitivity (allergy) to the drug to be used 7) Patients judged to be unsuitable by the research supervisor or the research co-workers
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takao Middle name Last name Ayuse
Organization	Nagasaki University
Division name	Dental Anesthesiology
Zip code	8528588
Address	Sakamoto Nagasaki Japan
TEL	81958197713
Email	ayuse@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Takao Middle name Last name Ayuse
Organization	Nagasaki University
Division name	Dental Anesthesiology
Zip code	8528588
Address	Sakamoto Nagasaki Japan
TEL	81958197713
Homepage URL
Email	ayuse@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Nagasaki University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nagasaki University
Address	Sakamoto Nagasaki Japan
Tel	81958197713
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	2020 Year 07 Month 29 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	2020 Year 05 Month 11 Day
Date of IRB	2020 Year 07 Month 29 Day
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	NONE

Management information
Registered date	2020 Year 07 Month 29 Day
Last modified on	2021 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047100