UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Change of respiratory mechanics during robot-assisted laparoscopic prostatectomy
Title of the study (Brief title)	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	daizoh satoh
Organization	Juntendo University School of Medicine
Division name	anesthesiology
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	Daizoh Satoh
Organization	Juntendo University School of Medicine
Division name	anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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