UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040650 |
|---|---|
| Receipt number | R000046399 |
| Scientific Title | Safety and feasibility of lung biopsy in diagnosis of acute respiratory distress syndrome; a systematic review and meta-analysis |
| Date of disclosure of the study information | 2020/06/08 |
| Last modified on | 2022/12/12 09:12:50 |
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Basic information
Public title
Safety and feasibility of lung biopsy in diagnosis of acute respiratory distress syndrome; a systematic review and meta-analysis
Acronym
Safety and feasibility of lung biopsy in diagnosis of acute respiratory distress syndrome; a systematic review and meta-analysis
Scientific Title
Safety and feasibility of lung biopsy in diagnosis of acute respiratory distress syndrome; a systematic review and meta-analysis
Scientific Title:Acronym
Safety and feasibility of lung biopsy in diagnosis of acute respiratory distress syndrome; a systematic review and meta-analysis
Region
| Japan |
Condition
Condition
ARDS patients and adult patients with ventilator management in the intensive care unit
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to perform systematic review and meta-analysis to evaluate the safety and feasibility of lung biopsy in diagnosis of patients with ARDS.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1Biopsy-related death
2Respiratory failure
3Cardiac complication
4Bleeding
Key secondary outcomes
1Pneumothorax
2Infection
3Cost
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with ARDS according to the Berlin criteria for adults or with acute respiratory failure requiring ventilator management in the intensive care unit.
Key exclusion criteria
Pediatric patient
Patients do not receive mechanical ventilation
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Fukuda |
Organization
Showa University School of Medicine
Division name
Department of medicine, Division of Respiratory medicine and Allergology
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8532
y.f.0423@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Fukuda |
Organization
Showa University School of Medicine
Division name
Department of medicine, Division of Respiratory medicine and Allergology
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8532
Homepage URL
y.f.0423@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
None.
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
None
Address
None
Tel
0337848532
y.f.0423@med.showa-u.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
| 2020 | Year | 06 | Month | 08 | 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
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
| 2020 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 11 | Month | 28 | Day |
Other
Other related information
1. Search methods
A systematic search of the literature will be conducted according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) Statement. We will search the following electrical databases; the Cochrane Central Resister of Controlled Trials (CENTRAL); MEDLINE via Ovid. Additionally, we will also search the other resources; the World health Organization International Clinical Trials Platform Search Portal (ICTRP) and ClinicalTrials.gov.
2. Assessing the risk of bias
To assess the risk of bias, we will use the McMaster Quality Assessment Scale of Harms (McHarm). Two reviewers will independently screen the full text of each study and decide whether the studies met the inclusion criteria. Any disagreement will be resolved by discussion or consulting the third reviewer.
3. Meta-analysis
Meta-analysis will be performed using statistical software, such as Review Manager 5.3.5, R, and STATA.
4.Sensitivity analysis
We will perform the sensitibity analysis by excluding from the meta-analysis studies at high risk of bias of the McMaster Quality Assessment Scale of Harms (McHarm).
5.Summary of findings table
SOF tables will be created for the following outcomes.
Primary outcomes:
1.Biopsy-related death
2. Respiratory failure
3. Cardiac complication and
4. Bleeding
Key secondary outcomes:
5. Pneumothorax
6. Infection
7. Cost
Management information
Registered date
| 2020 | Year | 06 | Month | 04 | Day |
Last modified on
| 2022 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046399
