UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021371 |
|---|---|
| Receipt number | 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 09:35:03 |
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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
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
kiyok@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024509
