UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042145 |
|---|---|
| Receipt number | 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 | 2021/11/02 17:10:18 |
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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
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
t.mihara@med.shimane-u.ac.jp
Sponsor or person
Institute
shimane university
Institute
Department
Personal name
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
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
| Delay expected |
Results Delay Reason
Our ICU is overwhelmed with COVID-19 patients.
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
| 2021 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048106
