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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034971
Receipt No. R000039875
Scientific Title A new method to detect air leakage in thoracic surgery using airway pressure reduction time
Date of disclosure of the study information 2018/11/30
Last modified on 2019/05/25

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Basic information
Public title A new method to detect air leakage in thoracic surgery using airway pressure reduction time
Acronym air leakage in thoracic surgery and airway pressure reduction time
Scientific Title A new method to detect air leakage in thoracic surgery using airway pressure reduction time
Scientific Title:Acronym air leakage in thoracic surgery and airway pressure reduction time
Region
Japan

Condition
Condition consecutive patients >= 18 years old scheduled to undergo elective thoracic surgery
Classification by specialty
Chest surgery Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study is to investigate the diagnostic methods to detect air leakage in thoracic surgery using airway pressure reduction time
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cutoff values of airway pressure reduction time to detect air leakage in thoracic surgery
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who undergo elective thoracic surgery
Key exclusion criteria no
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Seiichi
Middle name
Last name Shibasaki
Organization Saiseikai Yamaguchi grand hospital
Division name Division of Anesthesiology
Zip code 7530045
Address 2-11 Midorimatchi, Yamaguchi, Yamaguchi, Japan
TEL 0839016111
Email 95040ss@jichi.ac.jp

Public contact
Name of contact person
1st name Seiichi
Middle name
Last name Shibasaki
Organization Saiseikai Yamaguchi grand hospital
Division name Division of Anesthesiology
Zip code 7530045
Address 2-11 Midorimatchi, Yamaguchi, Yamaguchi, Japan
TEL 0839016111
Homepage URL
Email 95040ss@jichi.ac.jp

Sponsor
Institute Saiseikai Yamaguchi grand hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saiseikai Yamaguchi grand hospital
Address 2-11 Midorimatchi, Yamaguchi, Yamaguchi, Japan
Tel +81839016111
Email 95040ss@jichi.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

Other administrative information
Date of disclosure of the study information
2018 Year 11 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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
2018 Year 04 Month 25 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information measure airway pressure reduction time at air leakage test in thoracic surgery

Management information
Registered date
2018 Year 11 Month 21 Day
Last modified on
2019 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039875

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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