UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041071 |
|---|---|
| Receipt number | 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 | 2024/01/13 09:37:15 |
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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
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
ryoheiyamamoto11@gmail.com
Sponsor or person
Institute
Department of Healthcare Epidemiology, Graduate School of Medicine and Public Health, Kyoto University
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
See the article https://pubmed.ncbi.nlm.nih.gov/35660756/
Number of participants that the trial has enrolled
19864
Results
See the article https://pubmed.ncbi.nlm.nih.gov/35660756/
Results date posted
| 2024 | Year | 01 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
See the article https://pubmed.ncbi.nlm.nih.gov/35660756/
Participant flow
See the article https://pubmed.ncbi.nlm.nih.gov/35660756/
Adverse events
See the article https://pubmed.ncbi.nlm.nih.gov/35660756/
Outcome measures
See the article https://pubmed.ncbi.nlm.nih.gov/35660756/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 20 | Day |
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
| 2024 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.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 |
