UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041245 |
|---|---|
| Receipt number | R000047100 |
| Scientific Title | Examination of the influence on the circulatory system by the airway management method using Nasal High Flow load device AIRVO during sedation |
| Date of disclosure of the study information | 2020/07/29 |
| Last modified on | 2021/01/28 09:20:57 |
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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
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
ayuse@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047100
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
