UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038126
Receipt No. R000043453
Scientific Title Examination of airway management method in intravenous anesthesia using Nasal High
Date of disclosure of the study information 2019/10/09
Last modified on 2019/09/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Date trial data considered complete
Date analysis concluded

Other
Other related information

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


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.