UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046805 |
|---|---|
| Receipt number | R000053117 |
| Scientific Title | Comparison of ventilatory efficiency between PEEP0cmH2O and PEEP10cmH2O groups using EIT in robot-assisted laparoscopic prostatectomy |
| Date of disclosure of the study information | 2022/02/03 |
| Last modified on | 2024/09/06 15:10:25 |
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Basic information
Public title
Comparison of ventilatory efficiency between PEEP0cmH2O and PEEP10cmH2O groups using EIT in robot-assisted laparoscopic prostatectomy
Acronym
Ventilation efficiency using EIT in robot-assisted laparoscopic prostatectomy
Scientific Title
Comparison of ventilatory efficiency between PEEP0cmH2O and PEEP10cmH2O groups using EIT in robot-assisted laparoscopic prostatectomy
Scientific Title:Acronym
Ventilation efficiency using EIT in robot-assisted laparoscopic prostatectomy
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
During general anesthesia, it is well known that alveolar collapse causes a decrease in FRC (functional residual capacity) and an increase in intrapulmonary shunts, which adversely affect oxygenation. Inadequate PEEP can lead to alveolar collapse, and repeated collapse and dilation can cause lung injury. Too high PEEP can cause collapse of the circulation. In particular, robot-assisted laparoscopic prostatectomy (RALP) is associated with insufflation and trendelenburg position, which may lead to intraoperative and postoperative respiratory complications (PPC), and PEEP is thought to be effective in preventing them.However, the appropriate PEEP is unknown.
In this study, we will conduct a randomized controlled trial between two groups, low PEEP group and high PEEP group, with the goal of using EIT to determine the appropriate PEEP level during RALP surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
COV (center of ventilation) measured at EIT before intubation, after intubation, trendelenburg position, during pneumoperitoneum, before extubation, and after extubation.
Key secondary outcomes
ROI, GI index, lung compliance, Ppeak, and driving Pressure before intubation, after intubation, trendelenburg position, during pneumoperitoneum, before extubation and after extubation.
Effects on circulatory dynamics (HR, MAP, CI, CO, SVV) and blood gases before intubation, after intubation, trendelenburg position, during pneumoperitoneum, after extubation, 4 hours after ICU return, and at ICU discharge.
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
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
PEEP10 cmH2O
Interventions/Control_2
PEEP0 cmH2O
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
Adult patients undergoing robot-assisted laparoscopic prostatectomy.
Key exclusion criteria
Patients with severe cardiac/pulmonary disease, circulatory instability, inability to wear an EIT belt on the chest, and patients with pacemakers should be excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Michida |
Organization
Kawasaki Medical School General Medical Center
Division name
Department of Anesthesiology and Intensive Care
Zip code
700-8505
Address
2-6-1 Nakasange, Kita-ku, Okayama City, Okayama Prefecture
TEL
086-225-2111
mitchy0313kw@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Michida |
Organization
Kawasaki Medical School General Medical Center
Division name
Department of Anesthesiology and Intensive Care
Zip code
700-8505
Address
2-6-1 Nakasange, Kita-ku, Okayama City, Okayama Prefecture
TEL
086-225-2111
Homepage URL
mitchy0313kw@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School General Medical Center
Department of Anesthesiology and Intensive Care
Institute
Department
Personal name
Funding Source
Organization
None
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
Kawasaki Medical School General Medical Center
Address
2-6-1 Nakasange, Kita-ku, Okayama City, Okayama Prefecture
Tel
086-225-2111
mitchy0313kw@med.kawasaki-m.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
| 2022 | Year | 02 | Month | 03 | 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
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | 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
| 2022 | Year | 02 | Month | 02 | Day |
Last modified on
| 2024 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053117
