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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018884
Receipt No. R000021842
Scientific Title Current mechanical ventilation management during general anesthesia: a multicenter prospective observational study
Date of disclosure of the study information 2015/09/02
Last modified on 2016/02/17

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Basic information
Public title Current mechanical ventilation management during general anesthesia: a multicenter prospective observational study
Acronym Current mechanical ventilation management during general anesthesia: a multicenter prospective observational study
Scientific Title Current mechanical ventilation management during general anesthesia: a multicenter prospective observational study
Scientific Title:Acronym Current mechanical ventilation management during general anesthesia: a multicenter prospective observational study
Region
Japan

Condition
Condition Patients undergoing general anesthesia
Classification by specialty
Anesthesiology Operative medicine Intensive care medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to describe current mechanical ventilation practice during general anesthesia.
Basic objectives2 Others
Basic objectives -Others Another aim of this study is to help design an interventional study.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcomes are settings of mechanical ventilation 1 hour after the induction of general anesthesia (including FIO2, ventilation mode, respiratory rate, tidal volume, peak inspiratory pressure and PEEP).
Key secondary outcomes SpO2 and EtCO2 values 1 hour after the induction of general anesthesia.
Independent determinants of ventilator settings 1 hour after the induction of general anesthesia.

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We will include all patients who receive general anesthesia from 14 to 18 September 2015 or from 9 to 13 November 2015 at the participating hospitals (each participating hospital can choose whichever is more convenient).
Key exclusion criteria We will exclude all patients who receive general anesthesia within 1 hour.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Suzuki
Organization Okayama University Hospital
Division name Department of Intensive Care
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 086-235-7778
Email suzuki-s@mtc.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Suzuki
Organization Okayama University Hospital
Division name Department of Intensive Care
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 086-235-7778
Homepage URL http://www.okadaimasui.com/jp/clinicalstudy/index.html
Email suzuki-s@mtc.biglobe.ne.jp

Sponsor
Institute Okayama University Graduate School of Medicine and Dentistry, Department of Anesthesiology and Resuscitology
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
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 岡山大学病院(岡山県)
岡山旭東病院(岡山県)
岡山協立病院(岡山県)
岡山済生会病院(岡山県)
岡山市立市民病院(岡山県)
岡山赤十字病院(岡山県)
岡山労災病院(岡山県)
津山中央病院(岡山県)
国立病院機構 岡山医療センター(岡山県)
梶木病院(岡山県)
川崎医科大学附属川崎病院(岡山県)
川崎医科大学(岡山県)
倉敷成人病センター(岡山県)
松田病院(岡山県)
水島協同病院(岡山県)
屋島総合病院(岡山県)
香川県立中央病院(香川県)
香川労災病院(香川県)
三豊総合病院(香川県)
済生会今治病院(香川県)
滝宮総合病院(香川県)
尾道市立市民病院(広島県)
福山市市民病院(広島県)
国立病院機構 福山医療センター(広島県)
三原赤十字病院(広島県)
広島市民病院(広島県)
国立病院機構 岩国医療センター(山口県)
高砂市民病院(兵庫県)
神戸赤十字病院(兵庫県)
神戸大学医学部附属病院(兵庫県)
姫路聖マリア病院(兵庫県)
姫路赤十字病院(兵庫県)
姫路中央病院(兵庫県)
高知大学医学部附属病院(高知県)
近森病院(高知県)
愛宕病院(高知県)
高知医療センター(高知県)
鳥取市立病院(鳥取県)
舞鶴共済病院(京都府)
静岡がんセンター(静岡県)
国立がん研究センター 中央病院(東京都)
亀田総合病院(千葉県)
自治医科大学附属病院(栃木県)
昭和大学横浜市北部病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 02 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 08 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 14 Day
Last follow-up date
2015 Year 11 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We conduct a multicenter prospective observational study to describe current mechanical ventilation management during general anesthesia.
We will also investigate independent determinants of ventilator settings during general anesthesia.

Management information
Registered date
2015 Year 09 Month 02 Day
Last modified on
2016 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021842

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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