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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013888
Receipt No. 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

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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
Email 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
Email ds0226@fsinet.or.jp

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013437

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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