UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of ventilator mode for spontaneous respiration on open lung strategy evaluated by Electrical Impedance Tomography
Title of the study (Brief title)	An open lung strategy evaluated by Electrical Impedance Tomography
Region	Japan

Condition
Condition	Lung diseases Respiratory disorder caused by CNS disease
Classification by specialty	Pneumology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is to evaluate the effects of different respiratory mode on opening lung by Electrical Impedance Tomography
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes of regional pulmonary ventilation distribution after open lung strategy
Key secondary outcomes	Changes of pH,PaCO2,PaO2/FiO2 after open lung strategy

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Proportioanl assist ventilation mode
Interventions/Control_2	Open valve system
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	Patients with respiratory failure subjected to mechanical ventilation in Intensive care units at Tokyo Women's medical university hospital
Key exclusion criteria	any contraindication to the use of EIT (eg, a pacemaker, automatic implantable cardioverter defibrillator, or implantable pump).
Target sample size	40

Research contact person
Name of lead principal investigator	Makiko Komori
Organization	Tokyo Women's Medical University Medical Center East
Division name	Department of Anesthesiology
Address	2-1-10 Nishiogu, Arakawa-ku, Tokyo, Japan
TEL	03-3810-1111
Email	komorim@nifty.com

Public contact
Name of contact person	Junko Ichikawa
Organization	Tokyo Women's Medical University Medical Center East
Division name	Department of Anesthesiology
Address	2-1-10 Nishiogu, Arakawa-ku, Tokyo, Japan
TEL	03-3810-111
Homepage URL
Email	htwfx872@yahoo.co.jp

Sponsor
Institute	Department of Anesthesiology, Tokyo Women's Medical University Medical Center East
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University Medical Center East
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 09 Month 10 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 09 Month 06 Day
Anticipated trial start date	2016 Year 09 Month 10 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 09 Month 08 Day
Last modified on	2017 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027604