UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040348 |
|---|---|
| Receipt number | R000046044 |
| Scientific Title | Change in distribution of ventilation and aeration during bronchoalveolar lavage |
| Date of disclosure of the study information | 2020/05/10 |
| Last modified on | 2020/05/10 14:49:43 |
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Basic information
Public title
Change in distribution of ventilation and aeration during bronchoalveolar lavage
Acronym
EIT monitoring during bronchoalveolar lavage
Scientific Title
Change in distribution of ventilation and aeration during bronchoalveolar lavage
Scientific Title:Acronym
EIT monitoring during bronchoalveolar lavage
Region
| Japan |
Condition
Condition
acute respiratory failure
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the change in distribution of ventilation and aeration and lung mechanics during bronchoalveolar lavage
Basic objectives2
Others
Basic objectives -Others
lung mechanics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in End-expiratory lung impedance (EELI) duirng bronchoalveolar lavage
Key secondary outcomes
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)mechanically ventilated patients with strong spontaneous breath
2)age 20<=, <=85
3)admission on ICU
4)written informed consent
Key exclusion criteria
1)no indication for mechanical ventilation
2)haemodynamic instability with mean arterial pressure less than 55 mmHg
4) insuitable for EIT belt placement
5)heart beat supported by pacemaker
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Shono |
Organization
Showa university
Division name
Intensive care medicine
Zip code
142-8666
Address
Hantanodai1-5-9, Shinagawa, Tokyo, Japan
TEL
03-3784-8575
atsukos@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Shono |
Organization
Showa university
Division name
Intensive care medicine
Zip code
142-8666
Address
Hantanodai1-5-9, Shinagawa, Tokyo, Japan
TEL
03-3784-8575
Homepage URL
atsuko929shono@yahoo.co.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional review board
Address
Hantanodai1-5-9, Shinagawa, Tokyo, Japan
Tel
03-3784-8129
m-rinri@ofc.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 | 05 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Bronchoalveolar lavage (BAL) is a useful tool for the diagnostic evaluation and management of patients with pulmonary infection, interstitial lung disease, or malignancy. There exist concern about performing BAL in mechanically ventilated and hypoxemic patients that is associated with the loss of lung aeration and increase in shunt caused by the the procedure and resulting in impaired oxygenation. The impact of BAL on regional ventilation and aeration has not been fully investigated because of lack of monitoring tool. Electrical impedance tomography (EIT) is a promising non-invasive, radiation-free monitoring tool that can evaluate lung volume and efficient ventilation at the bedside in a real-time.The aim of study is to investigate the change in end-expiratory lung volume and ventilation as well as lung mechanics during BAL.
Management information
Registered date
| 2020 | Year | 05 | Month | 10 | Day |
Last modified on
| 2020 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046044
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
