UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the usefulness of positive end expiratory pressure and recruitment maneuver using change in gas distribution in lung observed from electric impedance tomography device in robotic-assisted laparoscopic prostatectomy during perioperative surgery
Acronym	Usefulness of PEEP and RM in robotic-assisted laparoscopic prostatectomy
Scientific Title	Evaluation of the usefulness of positive end expiratory pressure and recruitment maneuver using change in gas distribution in lung observed from electric impedance tomography device in robotic-assisted laparoscopic prostatectomy during perioperative surgery
Scientific Title:Acronym	Usefulness of PEEP and RM in robotic-assisted laparoscopic prostatectomy
Region	Japan

Condition
Condition	prostate cancer
Classification by specialty	Urology Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In order to search for more suitable artificial respiration setting to prevent atelectasis or hypoventilation in laparoscopic surgery with trendelenburg position, typified by robotic-assisted laparoscopic prostatectomy, we investigate the usefulness of positive end expiratory pressure and recruitment maneuver from transition of gas distribution change in lung and of functional residual capacity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in regional lung gas distribution obtained from EIT device and functional residual capacity change suggested by EELI among three groups with different settings of PEEP and RM at 8 time points (at the time of entering the room, introducing the general anesthesia, before starting the operation, 1 hour after the start of pneumoperitoneum and trendelenburg position, 2 hours after the start of pneumoperitoneum and trendelenburg position, immediately after the operation, 5 minutes afuter extubation).
Key secondary outcomes	Lung compliance obtained from ventilator and blood gas analysis result obtained by arterial blood sampling among three groups with different settings of PEEP and RM at 8 time points (at the time of entering the room, introducing the general anesthesia, before starting the operation, 1 hour after the start of pneumoperitoneum and trendelenburg position, 2 hours after the start of pneumoperitoneum and trendelenburg position, immediately after the operation, 5 minutes afuter extubation).

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Interventions 1: PEEP (2) RM (-)
Interventions/Control_2	Interventions 2: PEEP (10) RM (-)
Interventions/Control_3	Interventions 3: PEEP (10) RM (+)
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	100 years-old >=
Gender	Male
Key inclusion criteria	Adult patients undergoing robotic-assisted laparoscopic prostatectomy with ASA physical status 1-2
Key exclusion criteria	Patients under 20 years of age, pregnant women, Hugh-Jones class III or above, patients with bulla in the lung
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kiyoko Middle name Last name Bito
Organization	Showa University
Division name	Department of Anesthesiology
Zip code	1428555
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	03-3784-8000(ext.3540)
Email	kiyokobitoxxx@s5.dion.ne.jp

Public contact
Name of contact person	1st name Kiyoko Middle name Last name Bito
Organization	Showa University
Division name	Department of Anesthesiology
Zip code	1428555
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	03-3784-8000(ext.3540)
Homepage URL
Email	kiyokobitoxxx@s5.dion.ne.jp

Sponsor
Institute	Showa University Department of Anesthesiology
Institute
Department

Funding Source
Organization	Showa University Department of Anesthesiology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics|Showa University Hospital Clinical Trial Support Center
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
Tel	03-3784-8000
Email	ctsc.admin@ofc.showa-u.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	昭和大学病院

Other administrative information
Date of disclosure of the study information	2017 Year 06 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	Enrolling by invitation
Date of protocol fixation	2016 Year 09 Month 01 Day
Date of IRB	2014 Year 07 Month 24 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2020 Year 03 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 29 Day
Last modified on	2022 Year 07 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031450