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Recruitment status Terminated
Unique ID issued by UMIN UMIN000011289
Receipt No. R000013223
Scientific Title Efficacy of PPV/SVV ratio to assess dynamic arterial elastance in patients receiving differential lung ventilation
Date of disclosure of the study information 2013/07/27
Last modified on 2015/01/29

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Basic information
Public title Efficacy of PPV/SVV ratio to assess dynamic arterial elastance in patients receiving differential lung ventilation
Acronym Efficacy of PPV/SVV ratio to assess dynamic arterial elastance in patients receiving differential lung ventilation
Scientific Title Efficacy of PPV/SVV ratio to assess dynamic arterial elastance in patients receiving differential lung ventilation
Scientific Title:Acronym Efficacy of PPV/SVV ratio to assess dynamic arterial elastance in patients receiving differential lung ventilation
Region
Japan

Condition
Condition Lung tumor
Pneumothorax
Classification by specialty
Chest surgery Anesthesiology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To validate the efficacy of measuring pulse pressure variation /stroke volume variation ratio to assess dynamic arterial elastance
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between PPV/SVV ratio and blood pressure response by fluid loading during one lung ventilation
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who undergo thoracic surgery under general anesthesia
Key exclusion criteria Patients who have atrial fibrillation or atrial flutter.
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Katsuaki Tanaka
Organization Osaka City University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL 06-6645-2186
Email anesth@med.osaka-cu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Katsuaki Tanaka
Organization Osaka City University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL 06-6645-2186
Homepage URL
Email ethics@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka City University Graduate School of Medicine
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
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
2013 Year 07 Month 27 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 Terminated
Date of protocol fixation
2013 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information All subjects are divided into "Responder group" or "Non-responder group" according to intraoperative blood pressure change induced by fluid loading. Receiver operating characteristic curves of PPV/SVV ratio, SVV, PPV, and Pleth Variability Index are constructed to discriminate whether each subject is responder or non-responder.

Management information
Registered date
2013 Year 07 Month 26 Day
Last modified on
2015 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013223

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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