UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034417 |
|---|---|
| Receipt number | 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 | 2022/11/22 14:19:29 |
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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 | 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
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
shinsyu_k@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039239
