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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027532
Receipt No. R000031450
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
Date of disclosure of the study information 2017/06/01
Last modified on 2017/05/29

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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
Middle name
Last name Kiyoko Bito
Organization Showa University
Division name Department of Anesthesiology
Zip code
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
Middle name
Last name Kiyoko Bito
Organization Showa University
Division name Department of Anesthesiology
Zip code
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
Address
Tel
Email

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
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
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
2017 Year 05 Month 29 Day


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

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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