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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033980
Receipt No. R000038623
Scientific Title Effect of mechanical sputum assistance for ventilated patients in intensive care unit
Date of disclosure of the study information 2018/09/01
Last modified on 2019/08/01

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Basic information
Public title Effect of mechanical sputum assistance for ventilated patients in intensive care unit
Acronym Effect of mechanical sputum assistance for ventilated patients in intensive care unit
Scientific Title Effect of mechanical sputum assistance for ventilated patients in intensive care unit
Scientific Title:Acronym Effect of mechanical sputum assistance for ventilated patients in intensive care unit
Region
Japan

Condition
Condition Ventilated patients in the intensive care unit
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of Mechanical Insufflator-Exsufflator (MI-E) for ventilated patients in the intensive care unit.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of ventilatorv days
Number of ICU days
Key secondary outcomes rate of reintubatiorn
rate of tracheotomy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Use MI-E for 10 times at 40 cmH2O for ventilated patietns
Interventions/Control_2 ICU patients who received standard care only
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 ICU patients who required ventilation for at least 24h and expected for 48h
ICU patients who require lung physical therapy for exsufflation of sputum
Key exclusion criteria Patients whom principal investigators judge to be inappropriate for examinee.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kensuke Nakamura
Organization Hitachi General Hospital
Division name Department of emergency andi intensive care medicine
Zip code
Address 2-1-1, Jonancho, Hitachi city, Ibaraki prefecture
TEL 0294-23-1111
Email kensuke.nakamura.oz@hitachi.com

Public contact
Name of contact person
1st name
Middle name
Last name Kensuke Nakamura
Organization Hittachi Gerneral Hospital
Division name Department of emergency and intensive care medicine
Zip code
Address 2-1-1, Jonancho, Hitachi city, Ibaraki prefecture
TEL 0294-23-1111
Homepage URL
Email kensuke.nakamura.oz@hitachi.com

Sponsor
Institute Hittachi Gerneral Hospital
Institute
Department

Funding Source
Organization Hittachi Gerneral Hospital
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 01 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 38
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 Preinitiation
Date of protocol fixation
2017 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 01 Day
Last modified on
2019 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038623

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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