UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027532 |
|---|---|
| Receipt number | 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 | 2022/07/06 17:07:10 |
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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 | 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)
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
kiyokobitoxxx@s5.dion.ne.jp
Sponsor or person
Institute
Showa University
Department of Anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031450
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