UMIN-CTR Clinical Trial

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 Shinshu Middle name Last name Katayama
Organization	Jichi Medical University School of Medicine
Division name	Division of Intensive Care, Department of Anesthesiology and Intensive Care Medicine
Zip code	329-0498
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 Shinshu Middle name Last name Katayama
Organization	Jichi Medical University School of Medicine
Division name	Division of Intensive Care, Department of Anesthesiology and Intensive Care Medicine
Zip code	329-0498
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	Research Support Center, Jichi Medical University
Address	3311-1, Yakushiji, Shimotsuke, Tochigi, Japan
Tel	0285-58-8933
Email	rinri@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 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	100
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	2018 Year 10 Month 10 Day
Date of IRB	2018 Year 10 Month 03 Day
Anticipated trial start date	2018 Year 10 Month 10 Day
Last follow-up date	2022 Year 04 Month 25 Day
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	2022 Year 11 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039239