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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034417
Receipt No. R000039239
Scientific Title Evaluation of lung protective ventilation strategy during INTELLiVENT-ASV
Date of disclosure of the study information 2018/10/10
Last modified on 2018/12/06

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Basic information
Public title Evaluation of lung protective ventilation strategy during INTELLiVENT-ASV
Acronym Evaluation of lung protective ventilation strategy during INTELLiVENT-ASV
Scientific Title Evaluation of lung protective ventilation strategy during INTELLiVENT-ASV
Scientific Title:Acronym Evaluation of lung protective ventilation strategy during INTELLiVENT-ASV
Region
Japan

Condition
Condition Mechanical ventilated patients
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we aim to evaluate that INTELLiVENT-ASV is superior than usual care in the perspective of lung protective ventilation strategy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference of mechanical power
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Mechanical ventilated patients in ICU
Key exclusion criteria under 20 years old
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinshu Katayama
Organization Jichi Medical University School of Medicine
Division name Division of Intensive Care, Department of Anesthesiology and Intensive Care Medicine
Zip code
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, Japan
TEL 0285-44-2111
Email shinsyu_k@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinshu Katayama
Organization Jichi Medical University School of Medicine
Division name Division of Intensive Care, Department of Anesthesiology and Intensive Care Medicine
Zip code
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, Japan
TEL 0285-44-2111
Homepage URL
Email shinsyu_k@jichi.ac.jp

Sponsor
Institute Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization Jichi Medical University School of Medicine
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
2018 Year 10 Month 10 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 10 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

Management information
Registered date
2018 Year 10 Month 09 Day
Last modified on
2018 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039239

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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