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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029677
Receipt No. R000033911
Scientific Title Effect of alveolar recruitment maneuvers and positive end-expiratory pressure on postoperative atelectasis during general anesthesia for the laparoscopic nephrectomy and the robotically-assisted laparoscopic prostatectomy.
Date of disclosure of the study information 2017/11/30
Last modified on 2017/10/23

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Basic information
Public title Effect of alveolar recruitment maneuvers and positive end-expiratory pressure on postoperative atelectasis during general anesthesia for the laparoscopic nephrectomy and the robotically-assisted laparoscopic prostatectomy.
Acronym Effect of alveolar recruitment maneuvers and positive end-expiratory pressure for the laparoscopic nephrectomy and the robotically-assisted laparoscopic prostatectomy.
Scientific Title Effect of alveolar recruitment maneuvers and positive end-expiratory pressure on postoperative atelectasis during general anesthesia for the laparoscopic nephrectomy and the robotically-assisted laparoscopic prostatectomy.
Scientific Title:Acronym Effect of alveolar recruitment maneuvers and positive end-expiratory pressure for the laparoscopic nephrectomy and the robotically-assisted laparoscopic prostatectomy.
Region
Japan

Condition
Condition the laparoscopic nephrectomy and the robotically-assisted laparoscopic prostatectomy
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Assess the Effecacy of alveolar recruitment maneuvers and positive end-expiratory pressure on postoperative atelectasis during general anesthesia for the laparoscopic nephrectomy and the robotically-assisted laparoscopic prostatectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes postoperative atelectasis
Key secondary outcomes intraoperative and Postoperative oxygenation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 recruitment manuever
Interventions/Control_2 positive end-expiratory pressure
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
90 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing elective, the laparoscopic nephrectomy and the robotically-assisted laparoscopic prostatectomy under general anesthesia
Key exclusion criteria Abnormal pulmonary function
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuka Matsuki
Organization University of Fukui, Faculty of Medicine Sciences, Fukui, Japan
Division name Department of Anesthesiology & Reanimatology
Zip code
Address 23-3 Eiheijicho, Yoshidagun, Fukui 910-1193, Japan
TEL 0776-61-8391
Email ymatsuki@u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuka Matsuki
Organization University of Fukui, Faculty of Medicine Sciences, Fukui, Japan
Division name Department of Anesthesiology & Reanimatology
Zip code
Address 23-3 Eiheijicho, Yoshidagun, Fukui 910-1193, Japan
TEL 0776-61-8391
Homepage URL
Email ymatsuki@u-fukui.ac.jp

Sponsor
Institute Department of Anesthesiology & Reanimatology, University of Fukui, Faculty of Medicine Sciences, Fukui, Japan
Institute
Department

Funding Source
Organization None
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 30 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 08 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 13 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 10 Month 23 Day
Last modified on
2017 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033911

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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