UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017762 |
|---|---|
| Receipt number | R000020571 |
| Scientific Title | Bladder pressures during voluntary and involuntary cough and extubation outcomes in patients who have passed a spontaneous breathing trial |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2019/06/04 09:04:33 |
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Basic information
Public title
Bladder pressures during voluntary and involuntary cough and extubation outcomes in patients who have passed a spontaneous breathing trial
Acronym
Bladder Pressure diring cough and Extubation Outcome
Scientific Title
Bladder pressures during voluntary and involuntary cough and extubation outcomes in patients who have passed a spontaneous breathing trial
Scientific Title:Acronym
Bladder Pressure diring cough and Extubation Outcome
Region
| Japan |
Condition
Condition
Acute respiratory failure
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Endocrinology and Metabolism | Hematology and clinical oncology |
| Nephrology | Neurology | Clinical immunology |
| Psychosomatic Internal Medicine | Infectious disease | Geriatrics |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Endocrine surgery | Breast surgery |
| Neurosurgery | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the usefulness of peak Intra-abdominal pressure (IAP) and increase in IAP from baseline during voluntary and involuntary cough induced by suction catheter as predictors for successful extubation who are considered to be ready for extubation after successful SBT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Extubation failure
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 >17 years old who have been endotracheally intubated for respiratory failure and who have passed a SBT will be considered for study inclusion.
Key exclusion criteria
1)Patients younger than 18 year old
2)Patients who don't have Foley catheter
3)Patients with documented upper airway edema or known fixed airway obstruction
4)Patients who have a comfort care or do not re-intubate status
Target sample size
400
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
Division of Critical Care Medicine
Zip code
223-0064
Address
Yokohama, Japan
TEL
047-351-3101
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
Division of Critical Care Medicine
Zip code
223-0064
Address
Yokohama, Japan
TEL
047-351-3101
Homepage URL
norisue.yasuhiro@gmail.com
Sponsor or person
Institute
Yasuhiro Norisue
Institute
Department
Personal name
Funding Source
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Bay Urayasu Ichikawa Medical Center
Name of secondary funder(s)
NA
IRB Contact (For public release)
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Address
Yokohama, Japan
Tel
047-351-3101
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
東京ベイ浦安市川医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Intra-abdominal pressure during cough induced by suction catheter and voluntary cough before extubation will be measured via Foley catheter.
Management information
Registered date
| 2015 | Year | 06 | Month | 01 | Day |
Last modified on
| 2019 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020571
