UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025103 |
|---|---|
| Receipt number | R000028866 |
| Scientific Title | ORITM (Oxygen Reserve Index) values decrease in head-down position during robot-associated laparoscopic prostatectomy |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2016/12/01 16:16:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
ORITM (Oxygen Reserve Index) values decrease in head-down position during robot-associated laparoscopic prostatectomy
Acronym
RALP ORI headdown test
Scientific Title
ORITM (Oxygen Reserve Index) values decrease in head-down position during robot-associated laparoscopic prostatectomy
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Ishii Hisanari |
Organization
Tenri Hospital
Division name
Department of Anesthesia
Zip code
Address
200 Mishima-cho, Tenri, Nara, 632-8552, Japan
TEL
0743635611
naomi.ono.anesth@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ono Naomi |
Organization
Tenri Hospital
Division name
Department of Anesthesia
Zip code
Address
200 Mishima-cho, Tenri, Nara, 632-8552, Japan
TEL
0743635611
Homepage URL
naomi.ono.anesth@gmail.com
Sponsor or person
Institute
Tenri Hospital
Institute
Department
Personal name
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)
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
| 2016 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028866
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
