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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042145
Receipt No. R000048106
Scientific Title An evaluation of recordings of EIT during weaning from mechanical ventilation.
Date of disclosure of the study information 2020/10/23
Last modified on 2020/10/23

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Basic information
Public title An evaluation of recordings of EIT during weaning from mechanical ventilation.
Acronym An evaluation of recordings of EIT during weaning from mechanical ventilation.
Scientific Title An evaluation of recordings of EIT during weaning from mechanical ventilation.
Scientific Title:Acronym An evaluation of recordings of EIT during weaning from mechanical ventilation.
Region
Japan

Condition
Condition prolonged mechanical ventilation
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 observation of patients undesr prolonged mecahanical ventilation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes evaluation of recordings of EIT during weaning from mechanical ventilation
Key secondary outcomes Extubation outcome after spontaneous breathing trials

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients under prolonged mechanicai ventilatuion
Key exclusion criteria pregnancy
pneumothorax
fractured rib
fractured disorder
using muscle-relaxing drug
with internal pacemaker
Target sample size 100

Research contact person
Name of lead principal investigator
1st name toru
Middle name
Last name mihara
Organization shimane university
Division name ICU
Zip code 693-8501
Address shimane izumocity 89-1
TEL 0853-20-2295
Email t.mihara@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name toru
Middle name
Last name mihara
Organization shimane university
Division name ICU
Zip code 693-8501
Address shimane izumo city89-1
TEL 0853-20-2295
Homepage URL
Email t.mihara@med.shimane-u.ac.jp

Sponsor
Institute shimane university
Institute
Department

Funding Source
Organization shimane university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization shimane university
Address shimane izumo city89-1
Tel 0853202295
Email t.mihara@med.shimane-u.ac.jp

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
2020 Year 10 Month 23 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 Preinitiation
Date of protocol fixation
2018 Year 02 Month 09 Day
Date of IRB
2018 Year 02 Month 09 Day
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2020 Year 11 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information recording EIT during SBT

Management information
Registered date
2020 Year 10 Month 17 Day
Last modified on
2020 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048106

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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