UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023507 |
|---|---|
| Receipt number | R000023538 |
| Scientific Title | lung ultrasonography assessment for the patients undergoing thoracic surgery with general anesthesia |
| Date of disclosure of the study information | 2016/09/30 |
| Last modified on | 2016/09/07 22:00:46 |
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Basic information
Public title
lung ultrasonography assessment for the patients undergoing thoracic surgery with general anesthesia
Acronym
lung ultrasonography
Scientific Title
lung ultrasonography assessment for the patients undergoing thoracic surgery with general anesthesia
Scientific Title:Acronym
lung ultrasonography
Region
| Japan |
Condition
Condition
Thorasic surgery requiring one lung ventilation
Classification by specialty
| Chest surgery | Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We perform lung ultrasonography (LUS) in a patients under one lung ventilation and assess lung aeration loss using LUS scores described in previous reports. We also investigate whether there is an association between LUS scores and pulmonary complications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in LUS scores of dependent lung from the baselines.
Key secondary outcomes
1. Change in LUS scores of the non-dependent lung from the baselines.
2. Correlation between LUS scores and pulmonary complications.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Patients receive general anesthesia with one lung ventilation (OLV), and lung ultrasonography before and after OLV.
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) The patient who undergoes general anesthesia in Osaka national hospital
2) At the time of the anesthesia written consent acquisition, age is a patient 20 years or older.
3) It is a patient of class 1-3 by American Society of Anesthesiologists preoperation evaluation classification.
4) Sex: No object
5) The weight: No object
6) Having smoking or not: No object
7) A taste career: No object
8) A concomitant drug: No object
Key exclusion criteria
The applicable patient intends for even one following houses and excludes it.
1) It is a patient of class 4-6 by American Society of Anesthesiologists preoperation evaluation classification.
2) In addition, the patient who judged that the medical attendant of the final examination was inappropriate.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mari Sunohara |
Organization
Osaka National Hospital
Division name
Department of anesthesiology
Zip code
Address
2-1-14 Hoenzaka Chuo-ku Osaka city
TEL
06-6942-1331
sunohara@onh.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mari Sunohara |
Organization
Osaka National Hospital
Division name
Department of anesthesiology
Zip code
Address
2-1-14 Hoenzaka Chuo-ku Osaka city
TEL
06-6942-1331
Homepage URL
sunohara@onh.go.jp
Sponsor or person
Institute
Osaka National Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka National Hospital
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
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
| 2016 | Year | 09 | Month | 30 | 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
| 2015 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 05 | Day |
Last modified on
| 2016 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023538
