UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027195 |
|---|---|
| Receipt number | R000031163 |
| Scientific Title | Predictors Of Successful Extubation in critically ill patients: multicentre observational study |
| Date of disclosure of the study information | 2017/04/30 |
| Last modified on | 2020/05/14 09:31:33 |
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Basic information
Public title
Predictors Of Successful Extubation in critically ill patients: multicentre observational study
Acronym
POSE
Scientific Title
Predictors Of Successful Extubation in critically ill patients: multicentre observational study
Scientific Title:Acronym
POSE
Region
| Japan |
Condition
Condition
Intubation in Intensive Care Units
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the incidence and risk factors for extubation failure among critically ill patients who passed the 30 min spontaneous breathing test
Basic objectives2
Others
Basic objectives -Others
To establish the predict model of the successful extubation
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Reintubation within 48 hours after extubation
Key secondary outcomes
-Use of non-invasive positive pressure ventilation or nasal high flow within 48 hours after extubation
-Risk factors for extubation failure
-Length of ICU and hospital stay, vital status at ICU and hospital discharge
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
| 18 | years-old | <= |
Age-upper limit
| 200 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients extubated after successful spontaneous breathing test in the ICU
Key exclusion criteria
-Decision not to reintubate
-Unplanned extubation
-Extracorporeal circulation
-Patients who died within 48 hours after extubation
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Fujino |
Organization
Osaka University
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
5650871
Address
2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-5820
fujino@anes.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Fujino |
Organization
Osaka University
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
5650871
Address
2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-5820
Homepage URL
fujino@anes.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Intensive Care Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology and Intensive Care Medicine, Osaka University
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
Osaka university
Address
2-2 Yamadaoka Suita city Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
| 2017 | Year | 04 | Month | 30 | 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
513
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
EDC: REDCap
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment: patients admitted to ICU until April 30, 2019
Study Completion (anticipated): March 31, 2021
Management information
Registered date
| 2017 | Year | 04 | Month | 30 | Day |
Last modified on
| 2020 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031163
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
