UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038635 |
|---|---|
| Receipt number | R000043897 |
| Scientific Title | Randomized comparative study of the appearance of fixation and lip skin troubles due to differences in the shape of the double lumen bronchial tube flange |
| Date of disclosure of the study information | 2019/12/20 |
| Last modified on | 2021/11/29 12:51:39 |
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Basic information
Public title
Randomized comparative study of the appearance of fixation and lip skin troubles due to differences in the shape of the double lumen bronchial tube flange
Acronym
Randomized comparative study of the appearance of fixation and lip skin troubles due to differences in the shape of the double lumen bronchial tube flange
Scientific Title
Randomized comparative study of the appearance of fixation and lip skin troubles due to differences in the shape of the double lumen bronchial tube flange
Scientific Title:Acronym
Randomized comparative study of the appearance of fixation and lip skin troubles due to differences in the shape of the double lumen bronchial tube flange
Region
| Japan |
Condition
Condition
This is mainly intended for patients undergoing thoracic surgery requiring separate lung ventilation, such as lung cancer, pneumothorax, empyema, and mediastinal tumor.
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The shape of the flange (a device for fixing the bronchial tube body to the patient and adjusting the position) attached to the Daiken Medical Co., Ltd. coudec double lumen was changed and sold by the company. Since the tape fixing method has been changed with the flange shape change, the degree of bronchial tube displacement and countermeasures for lip skin problems due to flange fixing will be examined.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) New incidence: In each group, the number of new patients is divided by the number of target patients and calculated as a percentage.
Before and after tracheal intubation, observe the teeth and lips and exclude any damage caused by intubation.
2) Site and extent of damage:
The parts are classified into the lips, mouth corners, upper, lower, left and right around the mouth, the cheeks are above and below the nostrils, and the oral cavity is classified into the upper and lower parts of the alveoli and the tongue
The hard palate is excluded because it does not touch the structure.
3) Degree of damage: classified into redness, epidermal detachment, laceration, ulcer and blister
Sensory abnormalities include numbness, pain, and numbness
The range is described in mm (vertical * horizontal), and the depth is not evaluated because a measurable laceration is not expected.
Allows multiple selection of applicable items
Key secondary outcomes
1)Degree of bronchial tube displacement: When confirming the position of the tube with a bronchoscope, measure the distance (mm)from the tracheal branch to the tube opening for right lung ventilation to measure the extraction distance of the bronchoscope.
2)Safety assessment,Adverse events
Frequency of tube trouble: The case where the bronchial tube is displaced and the lung on the operation side swells or is inserted deeper and the position of the bronchial tube needs to be corrected during the operation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Existing flange group
Interventions/Control_2
New flange group
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
Intended for patients who meet all of the following criteria:
1)Patients undergoing thoracic surgery requiring separate lung ventilation
2) Patients using Daiken Medical Co., Ltd.'s codec double lumen left (37Fr/35Fr) 1)
3) Patients who are over 20 years old when obtaining consent (regardless of gender)
4) Patients who have received sufficient explanation for participation in this study, and who have obtained written consent from the patient or his / her proxy
1) Daiken Medical Equipment Co., Ltd. codec double lumen is sold only for the left side.
The new flange is not yet compatible with sizes 32Fr and 39Fr.
Key exclusion criteria
Patients who violate any of the following will not be included in this study:
1) Patients judged to be inappropriate by the study director
[Rationale for setting]
1) In order to leave room for the research director to decide whether or not to participate in this study, taking into account the general factors other than those mentioned above, taking into account the safety of the subject.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Kajikawa |
Organization
IZumi City General Hospital
Division name
Department manager of Anesthesiology
Zip code
594-0073
Address
4-5-1 Wake-cho Izumi Osaka Japan
TEL
0725411331
ryuji.kajikawa@tokushukai.jp
Public contact
Name of contact person
| 1st name | Ryuji |
| Middle name | |
| Last name | Kajikawa |
Organization
IZumi City General Hospital
Division name
Department manager of Anesthesiology
Zip code
594-0073
Address
4-5-1 Wake-cho Izumi Osaka Japan
TEL
0725411331
Homepage URL
ryuji.kajikawa@tokushukai.jp
Sponsor or person
Institute
IZumi City General Hospital
Institute
Department
Personal name
Funding Source
Organization
IZumi City General Hospital
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mirai Iryo Research Center Inc
Address
1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan
Tel
03-3263-4801
mirai-ec1@mirai-iryo.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
| 2019 | Year | 12 | Month | 20 | 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
Suspended
Date of protocol fixation
| 2019 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 19 | Day |
Last modified on
| 2021 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043897
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