UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050070 |
|---|---|
| Receipt number | R000057039 |
| Scientific Title | Perioperative thoracic dyskinesia and changes in respiratory muscle function in patients undergoing thoracoabdominal surgery |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/01/18 14:41:00 |
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Basic information
Public title
Perioperative thoracic dyskinesia and changes in respiratory muscle function in patients undergoing thoracoabdominal surgery
Acronym
Perioperative thoracic dyskinesia and changes in respiratory muscle function in patients undergoing thoracoabdominal surgery
Scientific Title
Perioperative thoracic dyskinesia and changes in respiratory muscle function in patients undergoing thoracoabdominal surgery
Scientific Title:Acronym
Perioperative thoracic dyskinesia and changes in respiratory muscle function in patients undergoing thoracoabdominal surgery
Region
| Japan |
Condition
Condition
Valvular heart disease, aortic dissection, angina pectoris, esophageal cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery | Cardiovascular surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to analyze perioperative thoracic movement disorders and changes in respiratory muscle function in thoracoabdominal surgery patients using respiratory muscle function assessment combined with 3-D motion analysis and electromyography.
Basic objectives2
Others
Basic objectives -Others
prospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained maximal inspiratory pressure
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
Key inclusion criteria
Cardiovascular and gastrointestinal surgery patients who are scheduled to undergo thoracoabdominal surgery on a waiting list and who have been referred to our rehabilitation department to start physical therapy prior to surgery.
Key exclusion criteria
Those with severe mental or cognitive impairment. Those with a history of pneumothorax, large pulmonary cysts, or aortic aneurysms.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Sato |
Organization
Kawasaki medical school
Division name
Department of Rehabilitation
Zip code
7100192
Address
Matsushima 577, Kurashiki, Okayama
TEL
0864621111
h0306@hp.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Sato |
Organization
Kawasaki medical school
Division name
Department of rehabilitation
Zip code
7100192
Address
Matsushima 577, Kurashiki, Okayama
TEL
0864621111
Homepage URL
h0306@hp.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki medical shcool
Institute
Department
Personal name
Funding Source
Organization
Kawasaki medical school
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
Kawasaki medical school
Address
Matsushima 577, Kurashiki, Okayama
Tel
0864621111
h0306@hp.kawasaki-m.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
岡山県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will analyze perioperative thoracic movement disorders and changes in respiratory muscle function in thoracoabdominal surgery patients using respiratory muscle function assessment combined with 3-D motion analysis and electromyography.
Management information
Registered date
| 2023 | Year | 01 | Month | 18 | Day |
Last modified on
| 2023 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057039
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
