UMIN-CTR Clinical Trial

Basic information
Public title	Influence of mandatory ventilation ratio on diaphragm weakness in critically ill patients
Acronym	Mandatory ventilation on diaphragm function
Scientific Title	Influence of mandatory ventilation ratio on diaphragm weakness in critically ill patients
Scientific Title:Acronym	Mandatory ventilation on diaphragm function
Region	Japan

Condition
Condition	Mechanically ventilated patients in ICU
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate if mandatory ventilation ratio during assist/control ventilation influences on diaphragmatic function and atrophy in ICU patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diaphragm thickning fraction 14 days after the start of mechanical ventilation or the day of extubation.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult patients supposed to be ventilated on asisst-control ventilation for longer than 48 hours in the intensive care unit.
Key exclusion criteria	diaphragmatic dysfunction, history of neuromuscular disease, pneumothorax, pneumomediastinum
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Taiga Itagaki
Organization	Tokushima University Hospital
Division name	Emergency and Critical Care medicine
Zip code
Address	3-18-15 Kuramotocho, Tokushima 770-8503
TEL	+81-88-633-9347
Email	taiga@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Taiga Itagaki
Organization	Tokushima University Hospital
Division name	Emergency and Critical Care medicine
Zip code
Address	3-18-15 Kuramotocho, Tokushima 770-8503
TEL	+81-88-633-9347
Homepage URL
Email	taiga@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University
Institute
Department

Funding Source
Organization	NONE
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

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 18 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	2018 Year 06 Month 18 Day
Date of IRB	2018 Year 07 Month 23 Day
Anticipated trial start date	2018 Year 06 Month 18 Day
Last follow-up date	2019 Year 07 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

If respiratory rate measured by the ventilator (RRpt, /min) is equal to set respiratory rate (RRset, /min), we define the minute "mandatory-ventilated minute". We calculate mandatory ventilation ratio for the period from the start of mechanical ventilation to the measurement of diaphragm function, and investigate the relationship between the ratio and morphological and functional changes in diaphragm.

Management information
Registered date	2018 Year 06 Month 11 Day
Last modified on	2019 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037560