UMIN-CTR Clinical Trial

Basic information
Public title	Effect of change in tidal volume on stroke volume variation during one lung ventilation
Acronym	TV and SVV during OLV
Scientific Title	Effect of change in tidal volume on stroke volume variation during one lung ventilation
Scientific Title:Acronym	TV and SVV during OLV
Region	Japan

Condition
Condition	General anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate effect of change in tidal volume on stroke volume variation(SVV) and respiratory mechanics during one lung ventilation for the patient who undergoing lung resection
Basic objectives2	Others
Basic objectives -Others	This study investigate whether SVV can provide an indication of volume status or not.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Effect of change in tidal volume on stroke volume variation
Key secondary outcomes	Effect of change in tidal volume on transpulmonary pressure Effect of change in driving pressure on stroke volume variation and transpulmonary pressure

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	The evaluetion of SVV and transpulmonary pressure are 9 times. Double and One lung ventilation (Tidal vilume 4ml/kg/ideal body weight,6ml/kg/ideal body weight,8ml/kg/ideal body weight)
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patient undergoing Vedeo-assisted thorasic surgery 2. American Society of Anesthesiologists 1or 2 3. Theagreement form is written.
Key exclusion criteria	1. Severe Chronic Obstructive Pulmonary Disease 2. Past history of lung resection or pneumothorax 3. Pulmonary hypertension 4. Uncontrolled hypertension 5. Severe heart failure 6. Arrhythmia 7. Taking diuretic drug 8. Chronic Kidny disease on dialysis 9. Body Mass Index under 35 10. Esophageal varices
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Nozomi Middle name Last name Katayama
Organization	Shimane University faculty of medicine
Division name	Department of Anaesthesiology
Zip code	6938501
Address	89-1 Enya-cho, izumo city, Shimane
TEL	0853-20-2295
Email	nk600113@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name Nozomi Middle name Last name Katayama
Organization	Shimane University faculty of medicine
Division name	Department of Anaesthesiology
Zip code	6938501
Address	89-1 Enya-cho, izumo city, Shimane
TEL	0853-20-2295
Homepage URL
Email	nk600113@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

Funding Source
Organization	None
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	Shimane University faculty of medicine, Department of Anaesthesiology
Address	89-1 Enya-cho, izumo city, Shimane
Tel	0853-20-2295
Email	nk600113@med.shimane-u.ac.jp

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	島根大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 20 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	2019 Year 10 Month 03 Day
Date of IRB	2019 Year 12 Month 26 Day
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 12 Month 20 Day
Last modified on	2022 Year 10 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044302