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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021371
Receipt No. R000024509
Scientific Title The effect of ventilatory tidal volume on lung injury during hepatectomy that requires transient liver blood flow interruption.
Date of disclosure of the study information 2016/03/07
Last modified on 2016/03/07

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Basic information
Public title The effect of ventilatory tidal volume on lung injury during hepatectomy that requires transient liver blood flow interruption.
Acronym The effect of ventilatory tidal volume on lung injury during hepatectomy that requires transient liver blood flow interruption.
Scientific Title The effect of ventilatory tidal volume on lung injury during hepatectomy that requires transient liver blood flow interruption.
Scientific Title:Acronym The effect of ventilatory tidal volume on lung injury during hepatectomy that requires transient liver blood flow interruption.
Region
Japan

Condition
Condition patients undergo hepatectomy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to clarify the effect of ventilation settings during surgery to lung injury
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes proinflammatory cytokine concentration in epithelial lining fluid during surgery
Key secondary outcomes oxygenation just after the surgery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
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 Prevention
Type of intervention
Other
Interventions/Control_1 Patients were ventilated with a tidal volume of 12 mL per predicted body weight (kg).
Interventions/Control_2 Patients were ventilated with a tidal volume of 6 mL per predicted body weight (kg).
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
85 years-old >=
Gender Male and Female
Key inclusion criteria patients undergoing hepatectomy
Key exclusion criteria Patients with an American Society of Anesthesiologists' physical status (ASA-PS) value of 3 and above, pre-existing lung disease, tumor in the portal vein or inferior vena cava, requirement of bile duct or gastrointestinal tract repair, or requirement of additional surgical procedures other than hepatectomy
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoyasu Kurahashi
Organization Yokohama City University Graduate School of Medicine
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2918
Email kiyok@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyoyasu Kurahashi
Organization Yokohama City University Graduate School of Medicine
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2918
Homepage URL
Email kiyok@med.yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University Hospital
Organization
Division
Category of Funding Organization Local Government
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 横浜市立大学附属病院(神奈川県)
Yokohama City University Hospital

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 07 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
2007 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2007 Year 08 Month 02 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
2016 Year 03 Month 07 Day
Last modified on
2016 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024509

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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