UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of diaphragm thickness ventilated patient in intensive care unit
Title of the study (Brief title)	Assessment of diaphragm thickness ventilated patient in intensive care unit
Region	Japan

Condition
Condition	ventilated patient
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess diaphragm thickness ventilated patient in intensive care unit
Basic objectives2	Others
Basic objectives -Others	epidemiological study
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	diaphragm thickness
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	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Echo.Once a day
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	18 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Mechanically ventilated patient
Key exclusion criteria	none
Target sample size	100

Research contact person
Name of lead principal investigator	Yuya Goto
Organization	Jichi Medical University hospital
Division name	Department of Anesthesiology and Intensive care Medicine
Address	3111-1 Yakushiji Shimotsuke-shi, Tochigi
TEL	0285-58-7392
Email	b_days@msn.com

Public contact
Name of contact person	Yuya Goto
Organization	Jichi Medical University hospital
Division name	Department of Anesthesiology and Intensive care Medicine
Address	3111-1 Yakushiji Shimotsuke-shi, Tochigi
TEL	0285-58-7392
Homepage URL
Email	b_days@msn.com

Sponsor
Institute	Jichi Medical university hospital
Institute
Department

Funding Source
Organization	Jichi Medical university hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 11 Month 11 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 11 Day
Last modified on	2016 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028530