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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036125
Receipt No. R000041154
Scientific Title Effect of lung recruitment on functional residual capacity measured by volumetric capnography
Date of disclosure of the study information 2019/03/08
Last modified on 2019/03/08

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Basic information
Public title Effect of lung recruitment on functional residual capacity measured by volumetric capnography
Acronym Effect of lung recruitment on functional residual capacity measured by volumetric capnography
Scientific Title Effect of lung recruitment on functional residual capacity measured by volumetric capnography
Scientific Title:Acronym Effect of lung recruitment on functional residual capacity measured by volumetric capnography
Region
Japan

Condition
Condition The patients under general anesthesia
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Anesthesiology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to examine functional residual capacity measured by volumetric capnography before, during and after automatic lung recruitment with the Flow-i Anesthesia machine
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Functional residual capacity measured by volumetric capnography before, during and after automatic lung recruitment
Key secondary outcomes lung compliance, airway dead space and alveolar dead space before, during and after automatic lung recruitment

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with general anesthesia
Key exclusion criteria 1. surgery in the lateral decubitus positon
2. surgery in the prone position
3. patients without tracheal intubation
4. history of pneumothorax
5. history of emphysema
6. lung resection cases
7. unstable hemodynamics during surgey
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Araki
Organization National Hospital Organization Nagasaki Medical center
Division name Department of Anesthesiology
Zip code
Address 2-1001-1,Kubara,Oomura,Nagasaki
TEL 0957523121
Email haraki@nagasaki-mc.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Araki
Organization National Hospital Organization Nagasaki Medical center
Division name Department of Anesthesiology
Zip code
Address 2-1001-1,Kubara,Oomura,Nagasaki
TEL 0957523121
Homepage URL
Email araki.hiroshi.je@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Nagasaki Medical center
Institute
Department

Funding Source
Organization No research fund
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
2019 Year 03 Month 08 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
2019 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2019 Year 03 Month 08 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041154

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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