UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048137 |
|---|---|
| Receipt number | R000054854 |
| Scientific Title | Clinical efficacy of bronchodilator delivery by vibrating mesh nebulizer in mechanical ventilated patients |
| Date of disclosure of the study information | 2022/06/23 |
| Last modified on | 2022/06/23 08:42:16 |
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Basic information
Public title
Clinical efficacy of bronchodilator delivery by vibrating mesh nebulizer in mechanical ventilated patients
Acronym
Clinical efficacy of bronchodilator delivery by vibrating mesh nebulizer in mechanical ventilated patients
Scientific Title
Clinical efficacy of bronchodilator delivery by vibrating mesh nebulizer in mechanical ventilated patients
Scientific Title:Acronym
Clinical efficacy of bronchodilator delivery by vibrating mesh nebulizer in mechanical ventilated patients
Region
| Japan |
Condition
Condition
Patients: Spontaneously breathing patients on mechanical ventilation with airway resistance of higher than 6 cmH2O/L/sec measured by PAV+.
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to compare the clinical efficacies of bronchodilator delivered by vibrating mesh nebulizer (VMN) with that delivered by metered dose inhaler (MDI) in mechanical ventilated patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Airway resistance and peak expiratory flow measured by PAV+
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Delivery of salbutamol 2.5mg by VMN
Interventions/Control_2
Delivery of salbutamol 0.8mg by MDI
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
-Spontaneously breathing patients (>17 years old) on mechanical ventilation with airway resistance of higher than 6 cmH2O/L/sec measured by proportional assist ventilation (PAV+TM) for whom clinicians decided to administer bronchodilator for appropriate clinical reasons.
Key exclusion criteria
-Hypersensitivity to salbutamol
-High airway resistance due to endotracheal obstruction
Target sample size
50
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
Critical care
Zip code
2790001
Address
3-4-32 Todaijima Urayasu Chiba
TEL
0473513101
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
Critical care
Zip code
223-0064
Address
3-4-32 Todaijima Urayasu Chiba
TEL
0473513101
Homepage URL
norisue.yasuhiro@gmail.com
Sponsor or person
Institute
Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Organization
Division
Category of Funding Organization
Other
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 Urayasu Chiba Japan
Tel
0473513101
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
| 2022 | Year | 06 | Month | 23 | 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
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 23 | Day |
Last modified on
| 2022 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054854
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
