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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048137
Receipt No. 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

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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
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 Critical care
Zip code 223-0064
Address 3-4-32 Todaijima Urayasu Chiba
TEL 0473513101
Homepage URL
Email norisue.yasuhiro@gmail.com

Sponsor
Institute Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department

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
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

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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054854

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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