UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045688 |
|---|---|
| Receipt number | R000052082 |
| Scientific Title | Evaluation of supraglottic Airway fitting using continuous breath sound monitoring |
| Date of disclosure of the study information | 2021/10/06 |
| Last modified on | 2022/04/08 16:32:24 |
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Basic information
Public title
Evaluation of supraglottic Airway fitting using continuous breath sound monitoring
Acronym
Evaluation of supraglottic Airway fitting using continuous breath sound monitoring
Scientific Title
Evaluation of supraglottic Airway fitting using continuous breath sound monitoring
Scientific Title:Acronym
Evaluation of supraglottic Airway fitting using continuous breath sound monitoring
Region
| Japan |
Condition
Condition
Patients undergoing elective surgery in general anesthesia with supraglottic airway
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We observe breath sound continuously and evaluate supraglottic airway's fitting by compairing frequency spectrum of breath sound ventilation volume.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of supraglottic airway's fitting by analyzing frequency spectrum of breath sound
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing elective surgery in general anesthesia with supraglottic airway
2. Patients who have provided their informed consent to participate in this study
Key exclusion criteria
Patients who have not provided their informed consent to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Shimamoto |
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name
Department of Anesthesiology
Zip code
737-0023
Address
3-1,Aoyama,Kure,Hiroshima,Japan
TEL
0823223111
j036eb@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Shimamoto |
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancwe Center
Division name
Department of Anesthesiology
Zip code
737-0023
Address
3-1,Aoyama,Kure,Hiroshima,Japan
TEL
0823223111
Homepage URL
j036eb@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Non.
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
Institutional reaview board at Kure Medical Center
Address
3-1,Aoyama,Kure,Hiroshima,Japan
Tel
0823223111
yokoo.reina.gs@mail.hosp.go.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
| 2021 | Year | 10 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 27 | 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
Non
Management information
Registered date
| 2021 | Year | 10 | Month | 06 | Day |
Last modified on
| 2022 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052082
