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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023507
Receipt No. 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

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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
Email 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
Email sunohara@onh.go.jp

Sponsor
Institute Osaka National Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023538

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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