UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002185 |
|---|---|
| Receipt number | R000002681 |
| Scientific Title | diagnostic bronchoalveolar lavage for the patients with acute respiratory failure during the non-invasive ventilation. |
| Date of disclosure of the study information | 2009/07/13 |
| Last modified on | 2014/09/02 19:54:45 |
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Basic information
Public title
diagnostic bronchoalveolar lavage for the patients with acute respiratory failure during the non-invasive ventilation.
Acronym
diagnostic BAL for the patients with acute respiratory failure during the NIV
Scientific Title
diagnostic bronchoalveolar lavage for the patients with acute respiratory failure during the non-invasive ventilation.
Scientific Title:Acronym
diagnostic BAL for the patients with acute respiratory failure during the NIV
Region
| Japan |
Condition
Condition
the patients with respiratory failure
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluated the safety and effect to perform bronchoscopy and BAL via face mask with NPPV for patients with respiratory failure.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the change of SpO2 during the procedure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The patients were underwent the BAL as the diagnostic procedure during the respiratory managements with NIV.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Enrolled patients in this study had respiratory failure, but they need to evaluate the BF or BAL.
Key exclusion criteria
apnea
cardiac instablity
uncontrolled hypoxia
(PaO2/FiO2<100 under NIV)
agitation
injury, burns, and abnormality on the face
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keishi Kubo |
Organization
Shinshu University School of Medicine
Division name
First Department of Internal Medicine
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
+81-263-37-2631
keishik@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiki Yokoyama |
Organization
Shinshu University School of Medicine
Division name
First Department of Internal Medicine
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2631
Homepage URL
toshikiyokoyama1978@hotmail.co.jp
Sponsor or person
Institute
First Department of Internal Medicine,
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
First Department of Internal Medicine,
Shinshu University School of Medicine
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
Address
Tel
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
信州大学医学部附属病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 07 | Month | 13 | 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
| 2009 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 11 | Day |
Last modified on
| 2014 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002681
