UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053311 |
|---|---|
| Receipt number | R000060854 |
| Scientific Title | Alveolar recruitment maneuvers during laparoscopic radical prostatectomy: A pilot randomized control study |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2024/01/10 16:21:59 |
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Basic information
Public title
Alveolar recruitment maneuvers during laparoscopic radical prostatectomy: A randomized control study
Acronym
ARM-lap-pRCT
Scientific Title
Alveolar recruitment maneuvers during laparoscopic radical prostatectomy: A pilot randomized control study
Scientific Title:Acronym
ARM-lap-pRCT
Region
| Japan |
Condition
Condition
Prostate Cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Alveolar recruitment maneuvers (RMs) would be plausible to maintain respiratory system compliance (Crs) during laparoscopic surgery, however, no concrete protocol has been established. We compared the changes in Cr and clinical outcomes using protocolized sequential RMs in every 30 min.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lung compliance during surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
PEEP (5-8 cmH2O) plus alveolar RM of 30 cmH2O for 20 sec
Interventions/Control_2
PEEP (5-8 cmH2O) only
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 and Female
Key inclusion criteria
elective laparoscopic radical prostatectomy under general anesthesia
Key exclusion criteria
ASA-PS more than equal 4
Severe lung disease
Patients who could not give consent
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Hosokawa |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Anesthesiology & Reanimatology
Zip code
910-1193
Address
23-3 Shimoaizuki, Matsuoka, Eiheijicho, Yoshidagun, Fukui
TEL
0776-61-8391
khosok@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Matsuki |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Anesthesiology & Reanimatology
Zip code
910-1193
Address
23-3 Shimoaizuki, Matsuoka, Eiheijicho, Yoshidagun, Fukui
TEL
0776618391
Homepage URL
ymatsuki@u-fukui.ac.jp
Sponsor or person
Institute
Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
This research received no specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of University of Fukui
Address
23-3 Shimoaizuki, Matsuoka, Eiheijicho, Yoshidagun, Fukui
Tel
0776618614
rinsho-rinri@ml.u-fukui.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
| 2025 | Year | 03 | Month | 31 | 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
36
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
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2024 | Year | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060854
