UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038126 |
|---|---|
| Receipt number | 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 | 2021/09/28 09:08:51 |
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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
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
ayuse@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
