UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040600 |
|---|---|
| Receipt number | 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 | 2021/10/13 11:50:41 |
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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
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
ekusiek_7@yahoo.co.jp
Sponsor or person
Institute
Department of Healthcare Epidemiology, Graduate School of Medicine and Public Health, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046332
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
