UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018884 |
|---|---|
| Receipt number | 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 14:23:05 |
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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
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
suzuki-s@mtc.biglobe.ne.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine and Dentistry, Department of Anesthesiology and Resuscitology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021842
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
