UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024883 |
|---|---|
| Receipt number | R000028633 |
| Scientific Title | Evaluation of the minimum pressure and volume in the bronchial cuff during one lung ventilation |
| Date of disclosure of the study information | 2016/11/17 |
| Last modified on | 2021/07/14 11:07:44 |
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Basic information
Public title
Evaluation of the minimum pressure and volume in the bronchial cuff during one lung ventilation
Acronym
Evaluation of the minimum pressure and volume in the bronchial cuff during one lung ventilation
Scientific Title
Evaluation of the minimum pressure and volume in the bronchial cuff during one lung ventilation
Scientific Title:Acronym
Evaluation of the minimum pressure and volume in the bronchial cuff during one lung ventilation
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The main object is to investigate the minimum bronchial cuff and volume during one lung ventilation. The second object is to examine the relation between the bronchial diameter and cuff volume.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether the operated lung is collapsed sufficiently
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intra bronchial cuff pressure is determined by a cuff pressure regulator at 20cmH2O.
Interventions/Control_2
The volume of the intra bronchial cuff is determined by the capnometer.
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
ASA physical status 1-2
20 years old or older
agreed to participate in the study and signed informed consent form
Key exclusion criteria
Patients with severe cerebra-vascular disease,coronary heart disease or respiratory failure
Target sample size
50
Research contact person
Name of lead principal investigator
| 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 City, Gifu
TEL
058-230-6404
y-comet@wg7.so-net.ne.jp
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 City, Gifu
TEL
058-230-6404
Homepage URL
y-comet@wg7.so-net.ne.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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 City, Gifu
Tel
058-230-6000
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
| 2016 | Year | 11 | Month | 17 | 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
64
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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 17 | Day |
Last modified on
| 2021 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028633
