UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030283 |
|---|---|
| Receipt number | R000034311 |
| Scientific Title | Optimization of respiratory management based on the Oxygen Reserved Index(ORI)for the RALP(Robotic Assisted Laparoscopic Prostatectomy)under da Vinci |
| Date of disclosure of the study information | 2017/12/06 |
| Last modified on | 2020/06/08 20:48:12 |
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Basic information
Public title
Optimization of respiratory management based on the Oxygen Reserved Index(ORI)for the RALP(Robotic Assisted Laparoscopic Prostatectomy)under da Vinci
Acronym
Optimization of respiratory management based on the Oxygen Reserved Index(ORI)for the RALP(Robotic Assisted Laparoscopic Prostatectomy)under da Vinci
Scientific Title
Optimization of respiratory management based on the Oxygen Reserved Index(ORI)for the RALP(Robotic Assisted Laparoscopic Prostatectomy)under da Vinci
Scientific Title:Acronym
Optimization of respiratory management based on the Oxygen Reserved Index(ORI)for the RALP(Robotic Assisted Laparoscopic Prostatectomy)under da Vinci
Region
| Japan |
Condition
Condition
Prostatic carcinoma
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Objection is to make a comparison of optimization of oxygenation by respiratory management based on the Oxigen Reserved Index (ORI) and SpO2 only for the RALP (Robotics Assisted LAparoscopic Postatectomy) under Da Vinci.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PaO2
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
We raise inhalational oxygen density and raise PEEP at the time SpO2 is less than 98%.
Interventions/Control_2
We try respiratory management to keep ORI less than 0.2.
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
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
Patients scheduled for Robotics Assisited Laparoscopic Prostatectomy by da Vinci.
Key exclusion criteria
cerebral ischemia
ocular hypertension
glaucoma
severe valvular disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Uchino |
Organization
Tokyo Medical University Hospital
Division name
Department of Anethesiology
Zip code
1600023
Address
6-7-1,Nishishinjuku,shinjuku-ku,Tokyo
TEL
0333426111
h-uchi@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Uchino |
| Middle name | |
| Last name | Hiroyuki |
Organization
Tokyo Medical University Hospital
Division name
Department of Anethesiology
Zip code
1600023
Address
6-7-1,Nishishinjuku,shinjuku-ku,Tokyo
TEL
0333426111
Homepage URL
h-uchi@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Hospital
Address
6-7-1,Nishishinjuku,shinjuku-ku,Tokyo
Tel
0333426111
yon0427.bonheur@gmail.com
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
東京医科大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 06 | 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
| 2017 | Year | 12 | Month | 06 | Day |
Last modified on
| 2020 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034311
