UMIN-CTR Clinical Trial

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	Main results already published
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 10 Month 13 Day

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