UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049320 |
|---|---|
| Receipt number | R000056166 |
| Scientific Title | Search for mask ventilation difficulty factors after neck radiotherapy |
| Date of disclosure of the study information | 2022/10/25 |
| Last modified on | 2023/04/27 07:37:10 |
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Basic information
Public title
Search for mask ventilation difficulty factors after neck radiotherapy
Acronym
Search for mask ventilation difficulty factors after neck radiotherapy
Scientific Title
Search for mask ventilation difficulty factors after neck radiotherapy
Scientific Title:Acronym
Search for mask ventilation difficulty factors after neck radiotherapy
Region
| Japan |
Condition
Condition
General anesthesia cases
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Retrospective search for predictors of mask ventilation difficulties in patients after neck radiotherapy using a single-center database.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mask ventilation difficulty
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing general anesthesia after radiation therapy to the upper airway
Key exclusion criteria
Patients not receiving radiation therapy to the upper airway
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Ishibashi |
Organization
Chiba University Hospital
Division name
Depatment of Anesthesiology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
katsu1484@gmail.com
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Ishsibashi |
Organization
Chiba University Hospital
Division name
Depatment of Anesthesiology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
Homepage URL
katsu1484@gmail.com
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
none
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
Chiba Graduate School of Medicine
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
043-222-7171
inohana-rinri@chiba-u.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
| 2022 | Year | 10 | Month | 25 | 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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
To perform a retrospective review of relevant cases extracted from the database of anesthesia records.
Mask ventilation difficulty and preoperative upper airway assessment and airway-related factors will be extracted and statistically analyzed in patients after neck radiotherapy.
Management information
Registered date
| 2022 | Year | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056166
