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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009316
Receipt No. R000010940
Scientific Title The effect of pneumoperitoneum on stroke volume variation
Date of disclosure of the study information 2012/11/12
Last modified on 2014/05/12

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Basic information
Public title The effect of pneumoperitoneum on stroke volume variation
Acronym The effect of pneumoperitoneum on stroke volume variation
Scientific Title The effect of pneumoperitoneum on stroke volume variation
Scientific Title:Acronym The effect of pneumoperitoneum on stroke volume variation
Region
Japan

Condition
Condition Laparoscopic surgical procedure under general anesthesia
Classification by specialty
Anesthesiology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate prospectively changes in stroke volume variation during pneumoperitoneum and laparoscopic surgery
Basic objectives2 Others
Basic objectives -Others Changes in stroke volume variation values
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes stroke volume variation values
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Immediately before pneumoperitoneum, baseline values are recorded, and the values are recorded again for 5 minutes after pneumoperitoneum. Furthermore, immediately before the end of pneumoperitoneum, baseline values are recorded, and the values are recorded again for 5 minutes after the end of pneumoperitoneum.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with ASA physical status 1 or 2
Key exclusion criteria Patients with a history of cardiac (including conduction abnormalities, arrhythmias, cardiovascular medication, etc.), pulmonary, or renal disease; pregnant patients
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Zen'ichiro Wajima
Organization Shioya hospital, International University of Health and Welfare
Division name Department of Anesthesiology
Zip code
Address 77 Tomita Yaita-shi, Tochigi, Japan
TEL 0287-44-1155
Email zwajima@iuhw.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Zen'ichiro Wajima
Organization International University of Health and Welfare
Division name Department of Anesthesiology
Zip code
Address 537-3 Iguchi, Nasushiobara-shi, Tochigi
TEL 0287-37-2221
Homepage URL
Email kazu-yoshinari@iuhw.ac.jp

Sponsor
Institute Department of Anesthesiology, Shioya hospital, International University of Health and Welfare
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
2012 Year 11 Month 12 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
2009 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 12 Day
Last follow-up date
Date of closure to data entry
2014 Year 05 Month 12 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 12 Day
Last modified on
2014 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010940

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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