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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name