UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049093 |
|---|---|
| Receipt number | R000055714 |
| Scientific Title | Development and clinical application of a cuff leak test which can distinguish between pharyngeal edema from laryngeal edema. |
| Date of disclosure of the study information | 2022/10/03 |
| Last modified on | 2025/04/05 19:59:26 |
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Basic information
Public title
Development and clinical application of a cuff leak test which can distinguish between pharyngeal edema from laryngeal edema.
Acronym
Development and clinical application of a cuff leak test which can distinguish between pharyngeal edema from laryngeal edema.
Scientific Title
Development and clinical application of a cuff leak test which can distinguish between pharyngeal edema from laryngeal edema.
Scientific Title:Acronym
Development and clinical application of a cuff leak test which can distinguish between pharyngeal edema from laryngeal edema.
Region
| Japan |
Condition
Condition
noncardiac surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is to construct a cuff leak test model to distinguish pharyngeal edema from laryngeal edema based on data obtained in a prospective observational study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cuff leak pressure (CLP)
Key secondary outcomes
Edema findings on laryngeal endoscopy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The cuff leak test before extubation.
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
Non-cardiac surgery cases undergoing general anesthesia.
Key exclusion criteria
Emergency surgery
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shiroh |
| Middle name | |
| Last name | Isono |
Organization
Chiba university hospital
Division name
Anesthesiology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
+81-43-222-7171
tomoharu.ukiya.915@gmail.com
Public contact
Name of contact person
| 1st name | Tomoharu |
| Middle name | |
| Last name | Ukiya |
Organization
Chiba university hospital
Division name
Anesthesiology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
0432227171
Homepage URL
tomoharu.ukiya.915@gmail.com
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
Chiba 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
Chiba university hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
0432227171
tomoharu.ukiya.915@gmail.com
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
| 2022 | Year | 10 | Month | 03 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Nothing.
Management information
Registered date
| 2022 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055714
