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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036376
Receipt No. R000041444
Scientific Title Ventilatory setting in patients undergoing robot assisted prostate surgery using transpulmonary pressure for titrating optimal PEEP.
Date of disclosure of the study information 2019/04/01
Last modified on 2019/04/01

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Basic information
Public title Ventilatory setting in patients undergoing robot assisted prostate surgery using transpulmonary pressure for titrating optimal PEEP.
Acronym Ventilatory setting in patients undergoing robot assisted prostate surgery using transpulmonary pressure.
Scientific Title Ventilatory setting in patients undergoing robot assisted prostate surgery using transpulmonary pressure for titrating optimal PEEP.
Scientific Title:Acronym PEEP titration using transpulmonary pressure in robot assisted prostate surgery.
Region
Japan

Condition
Condition Participants in this study will be the patients who fulfill the following criteria.
1.The patients who have prostatic cancer and will have elective robot-assisted surgery.
2.The age does not matter.
3.The patients with the risk 1 or 2 of the ASA(American Society of Anesthesiologist) .
4.The BMI of the patients is less than 35
5.The patients with NYHA1 and Hugh-Jones1
6.The patients who can sign a consent form to participate this study
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Robot assisted surgery (Da Vinci Surgery) has been applied to various kinds of operations. It is necessary to pay special attention to the respiratory management in robot assisted laparoscopic prostate (RALP) surgery, because of pneumoperitoneum and Trendelenburg position.
It has not necessarily been discussed how inspiratory and end expiratory pressure should be controlled during RALP surgery. Evaluating the stress on the the alveolar wall is important to prevent varotrauma while keeping the alvelus open,There are several methods to determine PEEP levels, among them, PEEP based on transpulmonary pressure has been attracting attention in ARDS. When the airway pressure at the end expiration is below the intrathoracic pressure, i.e. transpulmonary pressure at end expiration is less than 0, then the alveoli may collapse (pulmonary pressure equal airway pressure intrathoracic pressure). Intrathoracic pressure can be substituted with esophageal pressure measured by using an esophageal balloon catheter. It is speculated that intrathoracic pressure is elevated during RALP surgery, and lower PEEP will induce negative transpulmonary pressure and promotes alveolar atelectasis at the end of expiration.
The purpose of the study is to observe the changes in intrapleural pressure by increasing PEEP and to determine the optimal PEEP where transpulmonary pressure exceeds 0. We also observe the cardiac output and the cerebral oxygenation changes concomitantly with PEEP elevation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.transpulmonary pressure
2.airway pressure(peak airway pressure,inspiratory plateau pressure,mean airway pressure,PEEP)
3.esophageal pressure(peak,mean,end-expiratory)
4.P/F ratio
Key secondary outcomes 1.hart rate,arterial pressure
2.SpO2, ORI oxygen reserve index
3.arterial blood gas
4.lung thorax compliance
5.cerebral oxygen saturation:rSO2
6.Vigileo monitor Cardiac Output, Stroke Volume Stroke Volume Variation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 10cases
Duration of this study 2019.3.4-2019.12.31
The ventilation settings is normal until the operation starts.When head downed,pneumoperitoneum started,we add the PEEP from 0cmH2O to 15cmH2O by 5cmH20 up in every 30 minutes.Then the end expiratory airway pressure and esophageal pressure are monitored.
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

Not applicable
Gender Male
Key inclusion criteria Participants in this study will be the patients who fulfill the following criteria.
1.The patients who have prostatic cancer and will have elective robot-assisted surgery.
2.The age does not matter.
3.The patients with the risk 1 or 2 of the ASA(American Society of Anesthesiologist) .
4.The BMI of the patients is less than 35
5.The patients with NYHA1 and Hugh-Jones1
6.The patients who can sign a consent form to participate this study
Key exclusion criteria 1.The past history of a disorder of the central nervous system
2.The past of the thoracic operation.
3.The past of the myocardial infarction or heart failure
4.Problem with insertion in the esophagus.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Ami
Middle name
Last name Kodaira
Organization Tokyo Medical University Hospital
Division name department of anesthesia
Zip code 160-0023
Address 6-7-1 Nishishinjyuku,shinjyukuku,Tokyo
TEL 03-3342-6111
Email kodaami68@gmail.com

Public contact
Name of contact person
1st name Ami
Middle name
Last name Kodaira
Organization Tokyo Medical University Hospital
Division name department of anesthesiology
Zip code 160-0023
Address 6-7-1 Nishishinjyuku,shinjyukuku,Tokyo
TEL 03-3342-6111
Homepage URL
Email kodaami68@gmail.com

Sponsor
Institute Tokyo Medical University Hospital
Institute
Department

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 Center for Research Administration and Innovation, Tokyo Medical University.
Address 6-7-1 Nishishinjyuku,shinjyukuku,Tokyo
Tel 03-3342-6111
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
2019 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 04 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 04 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 01 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041444

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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