UMIN-CTR Clinical Trial

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	https://upload.umin.ac.jp/cgi-openbin/ ctr/ctr.cgi?function=brows&action=brows&recptno=R000041444&ty
Publication of results	Unpublished

Result
URL related to results and publications	https://upload.umin.ac.jp/cgi-openbin/ ctr/ctr.cgi?function=brows&action=brows&recptno=R000041444&ty
Number of participants that the trial has enrolled	14
Results	The median PEEP level associated with PtpEEP0 was 15 cmH2O. Respiratory system compliance values were higher at PtpEEP0 than those at PEEP5 (P = 0.02). Driving pressure was lower at PtpEEP0 than at PEEP5 (P=0.0036). The cardiac index remained unchanged, and the values of rSO2 were higher at PtpEEP0 than at PEEP0 (right; P=0.0019, left; P=0.036).
Results date posted	2022 Year 04 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	We enrolled male patients with the American Society of Anesthesiologists (ASA) Physical Status Classification score of 1 or 2 points, scheduled for RARP using a robotic operating system.
Participant flow	Written informed consent was obtained from 16 patients enrolled in the study. Two patients were excluded due to esophageal balloon catheter failure; a total of 14 patients were included.
Adverse events	No
Outcome measures	PEEP levels where endexpiratory Ptp levels of more than0 cmH2O were achieved (PtpEEP0). Airway pressure, esophageal pressure, cardiac index, and blood gas and rSO2 values after 30 minutes at each PEEP step.
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	2022 Year 04 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041444