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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000040650 |
Receipt No. | 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 | 2020/11/30 |
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 |
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Condition | ||
Condition | ARDS patients and adult patients with ventilator management in the intensive care unit | |
Classification by specialty |
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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 | |
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Eligibility | ||||
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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 |
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Name of lead principal investigator |
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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 |
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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 | |
Institute | Showa University |
Institute | |
Department |
Funding Source | |
Organization | None. |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
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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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046399 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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