UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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.