UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038939 |
|---|---|
| Receipt number | R000044302 |
| Scientific Title | Effect of change in tidal volume on stroke volume variation during one lung ventilation |
| Date of disclosure of the study information | 2019/12/20 |
| Last modified on | 2022/10/26 12:20:46 |
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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
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
nk600113@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044302
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
