UMIN-CTR Clinical Trial

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
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	Division of Critical Care Medicine
Zip code	223-0064
Address	Yokohama, Japan
TEL	047-351-3101
Homepage URL
Email	norisue.yasuhiro@gmail.com

Sponsor
Institute	Yasuhiro Norisue
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020571

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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