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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027264
Receipt No. R000029591
Scientific Title Prediction of fluid responsiveness in patients undergoing thoracoscopic esophagectomy with prone position.
Date of disclosure of the study information 2017/05/10
Last modified on 2018/03/02

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Basic information
Public title Prediction of fluid responsiveness in patients undergoing thoracoscopic esophagectomy with prone position.
Acronym Fluid responsiveness in patients undergoing thoracoscopic esophagectomy with prone position.
Scientific Title Prediction of fluid responsiveness in patients undergoing thoracoscopic esophagectomy with prone position.
Scientific Title:Acronym Fluid responsiveness in patients undergoing thoracoscopic esophagectomy with prone position.
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastrointestinal surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate whether dynamic parameters such as pulse pressure variation and stroke volume variation could predict fluid responsiveness in patients undergoing thoracoscopic esophagectomy with prone position, especially in thoracoscopic procedure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes ROC and AUC of PPV, SVV, PPV/SVV ratio, Heart rate, MAP and CVP to fluid responsiveness.
Key secondary outcomes The changes in PPV, SVV, PPV/SVV ratio, CI, heart rate, MAP and CVP before and after the fluid bolus.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Implementation period:day (during surgery)
Machine:Edwards Lifesciences
EV1000 and FloTrac sensor

When mean blood pressure decrease to 65 mmHg or less during thoracoscopic procedure with prone position, we have to inject 200ml of Hydroxyethyl Starch in sodium chloride injection (Voluven) will be administered over 10 minutes.
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 1)Patients with esophageal cancer undergoing thoracoscopic esophagectomy with prone position.
2)Patient who are 20 years or older.
3)Patients with ASA physical status of 3 or less.
4)Patients capable of giving written informed consent for the participation in this study.
Key exclusion criteria 1)Patients who are unable to have an operation with thoracoscopic approach.
2)Patients who cannot take prone position.
3)Patients who preoperatively have
cardiac arrhythmia.
4)history of myocardial ischemia.
5)unstable angina pectoris.
6)history of pulmonary edema or congestive heart failure.
7)severe liver dysfunction (AST or ALT of 100 IU/L or greater).
8)severe renal dysfunction (Creatinine of 3 mg/dl or greater, or undergoing dialysis).
9)intracranial hemorrhage.
10)severe hypernatremia or severe hyperchloremia.
11)Pregnant women or women of childbearing potential.
12)Lactating women.
13)Inability to fully comprehend and/or perform study procedures in the investigator opinion.
Target sample size 29

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Morimatsu
Organization Okayama University Graduate School of Medicine, Dentistry and
Pharmaceutical Science
Division name Department of Anesthesiology and Resuscitology
Zip code
Address 2-5-1 Kita-ku,Shikata-cho, Okayama
TEL 086-235-7778
Email morima-h@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukiko Hikasa
Organization Okayama University Hospital
Division name Department of intensive Care
Zip code
Address 2-5-1 Kita-ku,Shikata-cho, Okayama
TEL 086-235-7778
Homepage URL
Email ichi_go_ichi_e_kokoro@yahoo.co.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization Edwards Lifescience
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 10 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
2017 Year 03 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 10 Day
Last follow-up date
2018 Year 01 Month 31 Day
Date of closure to data entry
2018 Year 01 Month 31 Day
Date trial data considered complete
2018 Year 01 Month 31 Day
Date analysis concluded
2018 Year 03 Month 02 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 08 Day
Last modified on
2018 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029591

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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