UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2017 Year 11 Month 14 Day
Date of IRB	2017 Year 09 Month 13 Day
Anticipated trial start date	2017 Year 11 Month 14 Day
Last follow-up date	2019 Year 07 Month 31 Day
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	2020 Year 05 Month 25 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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