UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049950 |
|---|---|
| Receipt number | R000056595 |
| Scientific Title | Observational study for evaluating changes in bronchial cuff pressure during one-lung ventilation in thoracoscopic vs robotic surgery: a preliminary study |
| Date of disclosure of the study information | 2022/12/31 |
| Last modified on | 2022/12/31 21:01:10 |
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Basic information
Public title
Observational study for evaluating changes in bronchial cuff pressure during one-lung ventilation in thoracoscopic vs robotic surgery: a preliminary study
Acronym
Observational study for evaluating changes in bronchial cuff pressure during one-lung ventilation in thoracoscopic vs robotic surgery: a preliminary study
Scientific Title
Observational study for evaluating changes in bronchial cuff pressure during one-lung ventilation in thoracoscopic vs robotic surgery: a preliminary study
Scientific Title:Acronym
Observational study for evaluating changes in bronchial cuff pressure during one-lung ventilation in thoracoscopic vs robotic surgery: a preliminary study
Region
| Japan |
Condition
Condition
Lung surgery, mediastinal surgery
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The clarification of a higher likelihood of bronchial cuff pressure increasing following one-lung ventilation in robotic surgery compared to endoscopic surgery. Adjusting bronchial cuff pressure after opening the chest will reduce the risk of bronchial mucosa injury by the cuff .
The purpose of this study is the collection of information for designing the number of cases and determining a valid assessment index.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bronchial cuff pressure after chest opening
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 20 years of age or older having undergone endoscopic or robotic surgery requiring one-lung ventilation between August 1, 2022 and December 31, 2022
Key exclusion criteria
1) Patients not consenting to the use of their information by opting out
2) Patients presenting with severe respiratory dysfunction
3) Patients with a history of pneumonectomy (excluding partial pneumonectomy)
4) Patients with a tracheostomy
5) Height less than 150 cm
6)Obesity (BMI>35)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Kamiya |
Organization
Gifu University Graduate School of Medicine
Division name
Anesthesiology and Pain Medicine
Zip code
5011194
Address
1-1, Yanagido, Gifu-shi, Gifu
TEL
0582306404
yoshinori.kamiya@gmail.com
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Yamada |
Organization
Gifu University Graduate School of Medicine
Division name
Anesthesiology and Pain Medicine
Zip code
5011194
Address
1-1, Yanagido, Gifu-shi, Gifu
TEL
0582306404
Homepage URL
y-comet@wg7.so-net.ne.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Gifu University Graduate School of Medicine
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
Gifu University Graduate School of Medicine
Address
1-1, Yanagido, Gifu-shi, Gifu
Tel
0582306059
rinri@gifu-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
| 2022 | Year | 12 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to collect information for designing the number of cases and selecting valid endpoints for the study.
The following items will be obtained from the medical records. All of these items are collected in the course of routine medical care.
Age, medical history, subjective and objective symptoms,
Examination and evaluation items prior to the start of treatment
Examination and evaluation items during treatment
Examination and evaluation items at the end of treatment
Presence or absence of bronchial mucosa damage, presence or absence of subjective symptoms such as hoarseness and sore throat
Management information
Registered date
| 2022 | Year | 12 | Month | 31 | Day |
Last modified on
| 2022 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056595
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
