UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023981 |
|---|---|
| Receipt number | 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 16:23:03 |
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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
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
htwfx872@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology, Tokyo Women's Medical University Medical Center East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027604
