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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000017762 |
Receipt No. | 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 |
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 |
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Condition | ||||||||||||||||||||||
Condition | Acute respiratory failure | |||||||||||||||||||||
Classification by specialty |
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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 | |
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Interventions/Control_6 | |
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Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Target sample size | 400 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |