UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040600
Receipt No. R000046332
Scientific Title Safety of bronchoalveolar lavage for severe acute respiratory failure: systematic review and meta-analysis
Date of disclosure of the study information 2020/05/31
Last modified on 2021/06/01

* 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 of bronchoalveolar lavage for severe acute respiratory failure: systematic review and meta-analysis
Acronym Safety of bronchoalveolar lavage for severe acute respiratory failure: systematic review and meta-analysis
Scientific Title Safety of bronchoalveolar lavage for severe acute respiratory failure: systematic review and meta-analysis
Scientific Title:Acronym Safety of bronchoalveolar lavage for severe acute respiratory failure: systematic review and meta-analysis
Region
Japan

Condition
Condition Acute respiratory distress syndrome/acute lung injury, and severe respiratory failure
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of safety and adverse events of bronchoalveolar lavage in patients with ARDS/ALI and severe respiratory failure
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Death or serious disability
Key secondary outcomes 1) Life-threatening adverse events (e.g., exacerbation of respiratory status requiring new treatment, arrhythmias requiring intervention, reduction in blood pressure requiring intervention ,etc.)
2) Minor adverse events (e.g., temporary worsening of oxygenation)

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with severe respiratory failure such as acute respiratory distress syndrome and acute lung injury (also acceptable as defined by the authors) who were performed bronchoalveolar lavage
Key exclusion criteria 1) Patients with pre-existing PF-ILDs (e.g. idiopathic pulmonary fibrosis, collagen vascular disease-associated interstitial lung diseases, chronic hypersensitivity pneumonitis, etc.)
2) Patients with chronic respiratory failure
3) Patients with cardiac failure or fluid overload
4) Non-English studies
5) Studies of less than 10 patients with severe respiratory failure who were assessed for BAL
Target sample size 0

Research contact person
Name of lead principal investigator
1st name Keisuke
Middle name
Last name Anan
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
Email ekusiek_7@yahoo.co.jp

Public contact
Name of contact person
1st name Keisuke
Middle name
Last name Anan
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
Email ekusiek_7@yahoo.co.jp

Sponsor
Institute Department of Healthcare Epidemiology, Graduate School of Medicine and Public Health, Kyoto University
Institute
Department

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 Department of Healthcare Epidemiology, Graduate School of Medicine and Public Health, Kyoto University
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
Tel 075-753-4646
Email ekusiek_7@yahoo.co.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 05 Month 31 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 06 Month 01 Day
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information <Search method>
MEDLINE, etc.
<Assessment of risk of bias in included studies>
Two independent review authors will assess the risk of bias of the included studies using Newcastle-Otawa Scale tool or McMaster Quality Assessment Scale for Harms (McHarm). We will resolve discrepancies through discussion or consult a third review author if necessary.
<Meta-analysis>
We will use the Review Manager software (RevMan 5.1) and STATA ver.16.1 for statistical analysis. We will perform a quantitative analysis when studies are not heterogeneous. Random effects models will be used.
<Subgroup analysis>
We will perform the following subgroup analysis to investigate whether the frequencies of each adverse event are different among following the subgroups.
1. Age; younger than 65 years old, 65 years old or older
2. Mechanical ventilation when performing BAL; yes, no
3. The amount of BAL; 100~300ml (in accordance with the official American Thoracic Society clinical practice guideline), other (author definition)
<Sensitivity analysis>
We will perform the sensitivity analysis by excluding from the meta-analysis studies at high risk of bias of Newcastle-Otawa Scale tool.
<Summary of findings table>
We will create a summary of findings table for the following items;
participant, setting, description of BAL, number and percentage of deaths and serious sequelae, number and percentage of life-threatening adverse events (e.g., exacerbation of respiratory status requiring further treatment, arrhythmia requiring intervention, blood pressure reduction requiring intervention, etc.), number and percentage of minor adverse events (e.g., transient loss of oxygenation), quality assessment and comments

Management information
Registered date
2020 Year 05 Month 31 Day
Last modified on
2021 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046332

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.