UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027007 |
|---|---|
| Receipt number | 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 | 2021/10/19 09:05:32 |
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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
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
norisue.yasuhiro@gmail.com
Sponsor or person
Institute
Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department
Personal name
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
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
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
252
Results
Both PCED and diaphragm peak velocity during cough showed significant association with CPF, while only PCED predicted extubation failure with area under the curve of 0.791 (95% Cl 0.668-0.914).
Results date posted
| 2020 | Year | 04 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Two hundred fifty-two (252) mechanically ventilated patients with a successful SBT were enrolled in a prospective cohort study.
Participant flow
Two hundred fifty-two (252) mechanically ventilated patients with a successful SBT were enrolled in a prospective cohort study.
Adverse events
None
Outcome measures
Extubation failure
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 11 | Day |
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
| 2021 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030968
