UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044967 |
|---|---|
| Receipt number | R000051286 |
| Scientific Title | Optimization of respiratory management based on the Oxygen Reserved Index for the robotic assisted laparoscopic prostatectomy |
| Date of disclosure of the study information | 2021/07/28 |
| Last modified on | 2021/07/29 07:47:19 |
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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
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
m06046ys@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051286
