UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	ORITM (Oxygen Reserve Index) values decrease in head-down position during robot-associated laparoscopic prostatectomy
Title of the study (Brief title)	RALP ORI headdown test
Region	Japan

Condition
Condition	Prostate cancer
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the influence of extreme head don during robot-associated laparoscopic prostatectomy for Oxygen Reserve Index (ORI) and the relation between ORI and BMI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between BMI and ORI changes before and after posture change
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	none
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	80 years-old >
Gender	Male
Key inclusion criteria	The patient have no respiratory disease ASA PS 1 and 2
Key exclusion criteria	The patient have a respiratory disease
Target sample size	30

Research contact person
Name of lead principal investigator	Ishii Hisanari
Organization	Tenri Hospital
Division name	Department of Anesthesia
Address	200 Mishima-cho, Tenri, Nara, 632-8552, Japan
TEL	0743635611
Email	naomi.ono.anesth@gmail.com

Public contact
Name of contact person	Ono Naomi
Organization	Tenri Hospital
Division name	Department of Anesthesia
Address	200 Mishima-cho, Tenri, Nara, 632-8552, Japan
TEL	0743635611
Homepage URL
Email	naomi.ono.anesth@gmail.com

Sponsor
Institute	Tenri Hospital
Institute
Department

Funding Source
Organization	Tenri Hospital
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 12 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 09 Month 01 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 01 Day
Last modified on	2016 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028866