UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052494 |
|---|---|
| Receipt number | R000059792 |
| Scientific Title | Breathing-swallowing discoordination in lung transplantation candidates and lung transplant patients |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2023/10/13 17:31:39 |
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Basic information
Public title
Breathing-swallowing discoordination in lung transplantation candidates and lung transplant patients
Acronym
Breathing-swallowing discoordination in lung transplantation candidates and lung transplant patients
Scientific Title
Breathing-swallowing discoordination in lung transplantation candidates and lung transplant patients
Scientific Title:Acronym
Breathing-swallowing discoordination in lung transplantation candidates and lung transplant patients
Region
| Japan |
Condition
Condition
Chronic progressive lung disease with chronic respiratory failure
Classification by specialty
| Pneumology | Chest surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to prospectively validate breathing-swallowing patterns in patients with end-stage respiratory failure requiring lung transplantation and in post-lung transplant patients using swallow monitoring.
Basic objectives2
Others
Basic objectives -Others
This study aims to monitor swallowing status before and after lung transplantation using a swallow monitor to identify risk factors such as pre-transplant exacerbations and post-transplant rejection.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
breathing-swallowing pattern
Key secondary outcomes
Exacerbation or rejection at 1 year post-registration
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with chronic progressive lung disease with chronic respiratory failure
(2) Patients scheduled to be registered for brain-dead lung transplantation or immediately after brain-dead lung transplantation
(3) Age: 18 years or older at the time of consent
(4) Patients who have been fully informed about the participation in this study, and who have given their free and voluntary written consent based on a thorough understanding of the study.
Key exclusion criteria
(1) Obvious dysphagia at the time consent is obtained
(2) History of aspiration pneumonia
(3) Cerebrovascular disease
(4) Using dopamine agonists
(5) After a tracheotomy
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Nakao |
Organization
The University of Tokyo Hospital
Division name
Department of Thoracic Surgery
Zip code
113-8655
Address
7-3-1, Hongo Bunkyo-ku, Tokyo, JAPAN
TEL
03-3815-5411
nakaok-sur@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Yamaya |
Organization
The University of Tokyo Hospital
Division name
Department of Thoracic Surgery
Zip code
113-8655
Address
7-3-1, Hongo Bunkyo-ku, Tokyo, JAPAN
TEL
03-3815-5411
Homepage URL
yamayat-sur@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Keita Nakao
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hyogo Medical University
Advanced Medical Engineering Research Institute, University of Hyogo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Hospital
Address
7-3-1, Hongo Bunkyo-ku, Tokyo, JAPAN
Tel
03-3815-5411
nakaok-sur@h.u-tokyo.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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 01 | 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
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | 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
Other
Other related information
Cases are being accumulated.
Management information
Registered date
| 2023 | Year | 10 | Month | 13 | Day |
Last modified on
| 2023 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059792
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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