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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032235
Receipt No. 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

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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
Email 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
Email rdcyc910@yahoo.co.jp

Sponsor
Institute Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036762

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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