UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032235 |
|---|---|
| Receipt number | R000036762 |
| Scientific Title | Work of breathing measured by PAV+ during spontaneous breath trial and extubation outcome |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2018/04/13 16:00:32 |
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Basic information
Public title
Work of breathing measured by PAV+ during spontaneous breath trial and extubation outcome
Acronym
Work of breathing measured by PAV+ during spontaneous breath trial and extubation outcome
Scientific Title
Work of breathing measured by PAV+ during spontaneous breath trial and extubation outcome
Scientific Title:Acronym
Work of breathing measured by PAV+ during spontaneous breath trial and extubation outcome
Region
| Japan |
Condition
Condition
Adult patients are mechanically ventilated for acute respiratory failure
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether work of breathing measured by PAV+ predicts extubation failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Extubation failure
Respiratory failure after extubation
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All mechanically ventilated patients >18 years old who have been endotracheally intubated and who have passed a SBT
Key exclusion criteria
Patients with documented upper airway edema or known fixed airway obstruction
Patients who were underwent tracheostomy and have a comfort care or do not reintubate status
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Kataoka |
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Division name
Department of Critical Care Medicine
Zip code
Address
Todaijima 3-4-32, Urayasu, Chiba
TEL
047-351-3101
rdcyc910@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Kataoka |
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Division name
Department of Critical Care Medicine
Zip code
Address
Todaijima 3-4-32, Urayasu, Chiba
TEL
047-351-3101
Homepage URL
rdcyc910@yahoo.co.jp
Sponsor or person
Institute
Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2018 | Year | 05 | Month | 01 | 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 | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Work of breathing is measured by PAV+ during spontaneous breathing trial
Management information
Registered date
| 2018 | Year | 04 | Month | 13 | Day |
Last modified on
| 2018 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036762
