UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013888 |
|---|---|
| Receipt number | R000013437 |
| Scientific Title | Change of respiratory mechanics during robot-assisted laparoscopic prostatectomy |
| Date of disclosure of the study information | 2014/05/06 |
| Last modified on | 2018/10/29 19:27:36 |
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Basic information
Public title
Change of respiratory mechanics during robot-assisted laparoscopic prostatectomy
Acronym
Change of respiratory mechanics during robot-assisted laparoscopic prostatectomy
Scientific Title
Change of respiratory mechanics during robot-assisted laparoscopic prostatectomy
Scientific Title:Acronym
Change of respiratory mechanics during robot-assisted laparoscopic prostatectomy
Region
| Japan |
Condition
Condition
robot-assisted laparoscopic prostatectomy
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Trendelenburg position and pneumopertoneum may worsen chest wall elastance and decreasing transpulmonary pressure. Esophageal pressure is used for partioning respiratory mechanics between lung and chest wall.
Basic objectives2
Others
Basic objectives -Others
Trendelenburg position and pneumoperitoneum decreased functional residual capacity and did not change PaO2. Decreasing transpulmonary pressure is made by lung injury.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Trendelenburg position and pneumoperitoneum decreases transpulmonary pressure.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
esophageal pressure
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
| 70 | years-old | >= |
Gender
Male
Key inclusion criteria
ASA 1~2
Key exclusion criteria
renal failure, heart failure, lung disease
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | daizoh satoh |
Organization
Juntendo University School of Medicine
Division name
anesthesiology
Zip code
Address
2-1-2, Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL
+81-3-3813-3111
ds0226@fsinet.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daizoh Satoh |
Organization
Juntendo University School of Medicine
Division name
anesthesiology
Zip code
Address
2-1-2, Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL
+81-3-3813-3111
Homepage URL
ds0226@fsinet.or.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Anethesiology
Juntendo University School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 05 | Month | 06 | 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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 06 | Day |
Last modified on
| 2018 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013437
