UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013690 |
|---|---|
| Receipt number | R000015668 |
| Scientific Title | A pilot study for bronchial asthma attack treatment with high flow nasal cannula therapy |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2014/04/10 20:14:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A pilot study for bronchial asthma attack treatment with high flow nasal cannula therapy
Acronym
High flow nasal cannula therapy for bronchial asthma attack treatment
Scientific Title
A pilot study for bronchial asthma attack treatment with high flow nasal cannula therapy
Scientific Title:Acronym
High flow nasal cannula therapy for bronchial asthma attack treatment
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of high flow nasal cannula therapy with continuous isoproterenol nebulizer therapy in children with bronchial asthma severe attack
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Variation from the baseline value of modified pulmonary index score three hours after the start of treatments
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The patients of intervention group are treated their bronchial asthma attack with HFNC therapy and short acting beta 2 stimulate agonist nebulizer four times a day.
Interventions/Control_2
The patients of control group are treated their bronchial attack with continuous isoproterenol nebulizer therapy.
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
| 1 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient of bronchial asthma who is modified pulmonary index score 9 or more after administration of methylprednisolone 1 mg/kg and short acting beta 2 stimulate agonist nebulizer of two times or more within two hours prior to study initiation
Key exclusion criteria
The patients who cannot be obtained informed consent by themselves or their guardians. There is respiratory failure, shock, or disturbance of consciousness which requires mechanical ventilation. The patients with chronic lung disease, cyanotic heart disease, systemic disease that can exhibit wheezing, a history of arrhythmia provoked by beta 2 stimulate agonist, croup syndrome, suspicious of aspiration of foreign body, bronchiolitis, lobar atelectasis, pneumomediastinum, subcutaneous emphysema. The patient who the attending physician determines inappropriate.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinori Nakamura |
Organization
Showa University
Division name
Department of pediatrics
Zip code
Address
1-5-8 Hatanodai, Shinagawa ku, Tokyo
TEL
0337848000
toshinori@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshinori Nakamura |
Organization
Showa University
Division name
Department of pediatrics
Zip code
Address
Shonika ikyoku, 1-5-8 Hatanodai, Shinagawa ku, Tokyo
TEL
0337848000
Homepage URL
toshinori@med.showa-u.ac.jp
Sponsor or person
Institute
Department of pediatrics, Showa University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2014 | Year | 05 | 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
| 2013 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 10 | Day |
Last modified on
| 2014 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015668
