UMIN-CTR Clinical Trial

Basic information
Public title	Optimization of respiratory management based on the Oxygen Reserved Index for the robotic assisted laparoscopic prostatectomy
Acronym	Optimization of respiratory management based on the Oxygen Reserved Index for the robotic assisted laparoscopic prostatectomy
Scientific Title	Optimization of respiratory management based on the Oxygen Reserved Index for the robotic assisted laparoscopic prostatectomy
Scientific Title:Acronym	Optimization of respiratory management based on the Oxygen Reserved Index for the robotic assisted laparoscopic prostatectomy
Region	Japan

Condition
Condition	Prostatic carcinoma
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Investigate whether respiratory management monitoring ORI can avoid over-oxygenation for the robotics assisted laparoscopic postatectomy during surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of patients who were able to maintain a PaO2 of less than 120 mmHg during surgery.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	After patient identification, put on Masimo RD rainbow SET-2 sensor series and SpO2 sensor to patient's finger. O3 sensor is attached to the patient's forehead, rSO2 is measured at least 1 minute after the O3 sensor is attached before induction of anesthesia. After induction of anesthesia, lower FiO2 to 40% and set PEEP to 5 mmHg as initial setting. Perform arterial blood gas measurement at the following 5 times during the surgery. (After the start of surgery - before the start of insufflation, After 30 minutes of head-down position, After 1 hour of head-down position, After 2 hour of head-down position,After completion of insufflation) In the ORI group, adjust the ORI to be 0.01 to 0.1 during surgery.If ORI is 0.00, pressurize at 30 mmHg for 30 seconds,if ORI is still 0.00, increase FiO2. If ORI is greater than 0.1, decrease FiO2.
Interventions/Control_2	After patient identification, put on Masimo RD rainbow SET-2 sensor series and SpO2 sensor to patient's finger. O3 sensor is attached to the patient's forehead, rSO2 is measured at least 1 minute after the O3 sensor is attached before induction of anesthesia. After induction of anesthesia, lower FiO2 to 40% and set PEEP to 5 mmHg as initial setting. Perform arterial blood gas measurement at the following 5 times during the surgery. (After the start of surgery - before the start of insufflation, After 30 minutes of head-down position, After 1 hour of head-down position, After 2 hour of head-down position,After completion of insufflation) In the SpO2 group, the SpO2 be adjusted to maintain 98% or higher during surgery.If the SpO2 is less than 98%, pressurize at 30 mmHg for 30 seconds, and if the SpO2 is still less than 98%, increase the FiO2.
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	60 years-old <=
Age-upper limit	80 years-old >
Gender	Male
Key inclusion criteria	Patients who have given consent to participate in the research. Patients with Risk 1 or 2 prostate cancer as classified by the American Society of Anesthesiologist (ASA) Patients scheduled for robotics assisited laparoscopic prostatectomy.
Key exclusion criteria	Patients with any of the following cerebral ischemia interstitial pneumonia respiratory infection pneumothorax obstructive disorder(respiratory function test:less than 70% of FEV1.0%) restrictive disorder(respiratory function test: %VC less than 80%.) moderate to severe valve regurgitation(TR,MR,AR) glaucoma cognitive disorder BMI above 35 hypersensitivity to adhesive tape Patients who are deemed inappropriate for inclusion in the study by the principal investigator.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yonhi Middle name Last name Sai
Organization	Tokyo Medical University Hospital
Division name	Department of Anethesiology
Zip code	1600023
Address	6-7-1,Nishishinjuku,shinjuku-ku,Tokyo
TEL	0333426111
Email	m06046ys@tokyo-med.ac.jp

Public contact
Name of contact person	1st name Yonhi Middle name Last name Sai
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	m06046ys@tokyo-med.ac.jp

Sponsor
Institute	Tokyo Medical University Hospital
Institute
Department

Funding Source
Organization	Tokyo Medical Univerity 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	Tokyo Medical University Hospital Institutional Review Board
Address	6-7-1,Nishishinjuku,shinjuku-ku,Tokyo
Tel	0333426111
Email	Adm_IRB@tokyo-med.ac.jp

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	2021 Year 07 Month 28 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	2021 Year 04 Month 22 Day
Date of IRB	2021 Year 05 Month 21 Day
Anticipated trial start date	2023 Year 04 Month 01 Day
Last follow-up date	2024 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 07 Month 27 Day
Last modified on	2021 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051286