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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name