UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041074 |
|---|---|
| Receipt number | R000046911 |
| Scientific Title | Higher PEEP ventilation strategy in patients with acute respiratory distress syndrome: a systematic review and meta-analysis |
| Date of disclosure of the study information | 2020/07/12 |
| Last modified on | 2021/01/11 18:11:53 |
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Basic information
Public title
Higher PEEP ventilation strategy in patients with acute respiratory distress syndrome: a systematic review and meta-analysis
Acronym
Higher PEEP ventilation strategy in patients with acute respiratory distress syndrome: a systematic review and meta-analysis
Scientific Title
Higher PEEP ventilation strategy in patients with acute respiratory distress syndrome: a systematic review and meta-analysis
Scientific Title:Acronym
Higher PEEP 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 the higher PEEP in ARDS/ALI patients admitted to the ICU. We will examine whether a Higher PEEP ventilation strategy improves clinical outcomes, including mortality, compared with lower PEEP ventilation strategy.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
28-day mortality: If 28-day mortality is not reported, hospital mortality or mortality at the nearest-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: ADLs measured by one of the following
a) Barthel Index, Katz Index, DASC-21, Lawton
b) component of measurements of QOLs
c) Author's definition
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: PaO2, FiO2 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
We will include randomized controlled trials (RCTs or cluster RCTs). We will exclude crossover trials, quasi-randomized, non-randomized trials.
Types of participants
Inclusion Criteria (meet all)
16 years and older
ARDS or ALI
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
Graduate school of medicine and public health, Kyoto University Department of Healthcare Epidemiology
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 | 12 | Day |
Related information
URL releasing protocol
https://www.dropbox.com/s/9amkpzw09uj31hg/CQ10_higher%20PEEP%20vs%20lower%20PEEP_protocol_eng2020092
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
| 2020 | Year | 12 | 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 | 12 | Day |
Last modified on
| 2021 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046911
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/09/22 | CQ10_higher PEEP vs lower PEEP_protocol_eng20200922.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
