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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041071
Receipt No. R000046906
Scientific Title Low tidal volume ventilation strategy in patients with acute respiratory distress syndrome: a systematic review and meta-analysis
Date of disclosure of the study information 2020/07/11
Last modified on 2020/10/07

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Basic information
Public title Low tidal volume ventilation strategy in patients with acute respiratory distress syndrome: a systematic review and meta-analysis
Acronym Low tidal volume ventilation strategy in patients with acute respiratory distress syndrome: a systematic review and meta-analysis
Scientific Title Low tidal volume ventilation strategy in patients with acute respiratory distress syndrome: a systematic review and meta-analysis
Scientific Title:Acronym Low tidal volume ventilation strategy in patients with acute respiratory distress syndrome: a systematic review and meta-analysis
Region
Japan

Condition
Condition Acute respiratory distress syndrome (ARDS)
Classification by specialty
Pneumology Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this systematic review is to evaluate the effects of lower tidal volume ventilation in ARDS/ALI patients admitted to the ICU. We will examine whether lower tidal volume ventilation improves clinical outcomes, including mortality, compared with the usual ventilation strategy.
Basic objectives2 Others
Basic objectives -Others not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 28-day mortality: If 28-day mortality is not reported, hospital mortality or mortality at the nearest follow-up at 28-day regardless of the duration of follow-up will be employed. If the Kaplan-Meier curve is reported, it is read from that figure.
Key secondary outcomes Long-term mortality: longest follow-up regardless of the duration of follow-up will be employed
ADLs.
QoL: A QoL measured by one of the following
a) Short Form 36 (SF-36) (18)
b) Health Assessment Questionnaire (HAQ)
c) Sick ness profile impact (SIP)(19)
d) other

P/F ratio: P/F ratio for Day 1 (not including the baseline)
VFD at 28: Ventilation free day up to 28 days.
Barotrauma/VILI: New pneumothorax, mediastinal emphysema, subcutaneous emphysema, new thoracic drainage or author-defined Barotrauma/VILI.

Base
Study type Others,meta-analysis etc

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 Inclusion Criteria (meet all)
16 years and older
ARDS or ALI.
On invasive mechanical ventilation
The definition of ARDS or ALI is one of the following.
a) The North-American-European Consensus Conference on ARDS (NAECC) (Bernard 1994) (3)
b) The Lung Injury Severity Score (LISS) (Murray 1988)(17)
c) The Berlin definition (Ranieri 2012)(4,17)
d) Other author's definition"
Key exclusion criteria Exclusion criteria (any of which are met)
Controlled by noninvasive ventilation (NIV)
Target sample size 0

Research contact person
Name of lead principal investigator
1st name Ryohei
Middle name
Last name Yamamoto
Organization Graduate school of medicine and public health, Kyoto University
Division name Department of Healthcare Epidemiology
Zip code 606-8501
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL 075-753-4646
Email ryoheiyamamoto11@gmail.com

Public contact
Name of contact person
1st name Ryohei
Middle name
Last name Yamamoto
Organization Graduate school of medicine and public health, Kyoto University
Division name Department of Healthcare Epidemiology
Zip code 606-8501
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL 075-753-4646
Homepage URL
Email ryoheiyamamoto11@gmail.com

Sponsor
Institute Department of Healthcare Epidemiology, Graduate School of Medicine and Public Health, Kyoto University
Institute
Department

Funding Source
Organization self funding
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 not applicable
Address not applicable
Tel not applicable
Email not applicable

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
2020 Year 07 Month 11 Day

Related information
URL releasing protocol https://www.dropbox.com/s/tsf7nguk3tl1910/lower%20tidal%20volume%20ventilation_protocol20201007_eng.
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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 20 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded
2021 Year 04 Month 30 Day

Other
Other related information See attached file for more details on the protocol.

Management information
Registered date
2020 Year 07 Month 11 Day
Last modified on
2020 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046906

Research Plan
Registered date File name
2020/10/07 lower tidal volume ventilation_protocol20201007_eng.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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