UMIN-CTR Clinical Trial

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
Email	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
Email	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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	None
Address	None
Tel	0337848532
Email	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	Preinitiation
Date of protocol fixation	2020 Year 05 Month 31 Day
Date of IRB
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	2020 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046399

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.