UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036794 |
|---|---|
| Receipt number | R000041918 |
| Scientific Title | The influence of changes in tongue pressure on postoperative dysphagia in mechanical ventilated patients after cardiovascular surgery. |
| Date of disclosure of the study information | 2019/05/21 |
| Last modified on | 2023/01/01 05:34:52 |
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Basic information
Public title
The influence of changes in tongue pressure on postoperative dysphagia in mechanical ventilated patients after cardiovascular surgery.
Acronym
The influence of changes in tongue pressure on postoperative dysphagia in mechanical ventilated patients after cardiovascular surgery.
Scientific Title
The influence of changes in tongue pressure on postoperative dysphagia in mechanical ventilated patients after cardiovascular surgery.
Scientific Title:Acronym
The influence of changes in tongue pressure on postoperative dysphagia in mechanical ventilated patients after cardiovascular surgery.
Region
| Japan |
Condition
Condition
cardiovascular surgery
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Does the change in tongue pressure in patients who require mechanical ventilation after cardiovascular surgery affect the occurrence of postoperative dysphagia?
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Can we predict postoperative dysphagia?
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Open-heart surgery and major vessel surgery
Mechanical ventilation with endotracheal intubation after cardiovascular surgery
Key exclusion criteria
Unconscious
The person in charge of research judged it to be inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Yamada |
Organization
Toho University Omori Medical Center
Division name
Nursing department
Zip code
143-8541
Address
6-11-1 Omori Nishi, Ota-ku, Tokyo
TEL
03-3762-4151
tooru-yamada@ns.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Yamada |
Organization
Toho University Omori Medical Center
Division name
Nursing department
Zip code
143-8541
Address
Toho University Omori Medical Center
TEL
03-3762-4151
Homepage URL
tooru-yamada@ns.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Toho University Omori Medical Center
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
Toho University Omori Medical Center Ethics Committee Bureau
Address
6-11-1,Omorinishi,Ota-ku,Tokyo
Tel
03-3762-4151
omori.rinri@ext.toho-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
| 2019 | Year | 05 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ijccm.org/abstractArticleContentBrowse/IJCCM/64/26/12/31158/abstractArticle/Article
Number of participants that the trial has enrolled
68
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Currently writing a paper.
Date of the first journal publication of results
| 2022 | Year | 12 | Month | 08 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 31 | Day |
Other
Other related information
Prospective observational research.
The tongue pressure of the patient is measured preoperatively, 6 hours, 3 days and 7 days after extubation. As for indicators of dysphagia after extubation, the results of swallowing function evaluation and clinical findings of dysphagia are extracted.
Management information
Registered date
| 2019 | Year | 05 | Month | 20 | Day |
Last modified on
| 2023 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041918
