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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023981
Receipt No. R000027604
Scientific Title The effect of ventilator mode for spontaneous respiration on open lung strategy evaluated by Electrical Impedance Tomography
Date of disclosure of the study information 2016/09/10
Last modified on 2017/12/15

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Basic information
Public title The effect of ventilator mode for spontaneous respiration on open lung strategy evaluated by Electrical Impedance Tomography
Acronym An open lung strategy evaluated by Electrical Impedance Tomography
Scientific Title The effect of ventilator mode for spontaneous respiration on open lung strategy evaluated by Electrical Impedance Tomography
Scientific Title:Acronym 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
1st name
Middle name
Last name Makiko Komori
Organization Tokyo Women's Medical University Medical Center East
Division name Department of Anesthesiology
Zip code
Address 2-1-10 Nishiogu, Arakawa-ku, Tokyo, Japan
TEL 03-3810-1111
Email komorim@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Junko Ichikawa
Organization Tokyo Women's Medical University Medical Center East
Division name Department of Anesthesiology
Zip code
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)

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
2016 Year 09 Month 10 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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 06 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000027604

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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