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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027007
Receipt No. R000030968
Scientific Title Diaphragmatic excursion and velocity during cough and extubation outcomes in patients who have passed a spontaneous breathing trial
Date of disclosure of the study information 2017/04/16
Last modified on 2019/04/18

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Basic information
Public title Diaphragmatic excursion and velocity during cough and extubation outcomes in patients who have passed a spontaneous breathing trial
Acronym Diaphragmatic excursion and velocity during cough and extubation outcomes
Scientific Title Diaphragmatic excursion and velocity during cough and extubation outcomes in patients who have passed a spontaneous breathing trial
Scientific Title:Acronym Diaphragmatic excursion and velocity during cough and extubation outcomes
Region
Japan

Condition
Condition All mechanically ventilated patients >18 years old who have been endotracheally intubated for respiratory failure and who have passed a SBT and follow commands will be considered for study inclusion. Successful completion of an SBT will be determined by the standard Tokyo Bay Urayasu Ichikawa Medical center Intensive Care Weaning Protocols (no evidence of severe anxiety, dyspnea, excessive accessory muscle use, RSBI>105 breaths/min/L, and adequate gas exchange on 50% FIO2 or less).
Classification by specialty
Medicine in general Surgery in general Vascular surgery
Intensive care medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine if diaphragmatic motion and the velocity (cm/sec) during cough measured by ultrasonography can be predictors for effective cough to clear secretions, therefore predictors for successful extubation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Re-intubation
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 for respiratory failure and who have passed a SBT and follow commands
Key exclusion criteria Patients with documented upper airway edema or known fixed airway obstruction will be excluded from the study
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Yasuhiro
Middle name
Last name Norisue
Organization Tokyo Bay Urayasu Ichikawa Medical Center
Division name Pulmonary and Critical Care Medicine
Zip code 2790001
Address 3-4-32 Todaijima, Urayasushi, Chiba, Japan
TEL +8108058959696
Email norisue.yasuhiro@gmail.com

Public contact
Name of contact person
1st name Yasuhiro
Middle name
Last name Norisue
Organization Tokyo Bay Urayasu Ichikawa Medical Center
Division name Pulmonary and Critical Care Medicine
Zip code 2790001
Address 3-4-32 Todaijima, Urayasushi, Chiba, Japan
TEL +8108058959696
Homepage URL
Email norisue.yasuhiro@gmail.com

Sponsor
Institute Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department

Funding Source
Organization NA
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 Tokyo Bay Urayasu Ichikawa Medical Center
Address 3-4-32 Todaijima,
Tel 047-351-3101
Email norisue.yasuhiro@gmail.com

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 16 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2017 Year 04 Month 16 Day
Last modified on
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030968

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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