UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015285 |
|---|---|
| Receipt number | R000017776 |
| Scientific Title | Effects of automed sputum aspirating device for the patients with intractable neurological disease using tracheotomy positive pressure ventilation (TPPV) in long-term care bed. |
| Date of disclosure of the study information | 2014/09/30 |
| Last modified on | 2015/04/18 21:24:23 |
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Basic information
Public title
Effects of automed sputum aspirating device for the patients with intractable neurological disease using tracheotomy positive pressure ventilation (TPPV) in long-term care bed.
Acronym
Effects of automated sputum aspirating device.
Scientific Title
Effects of automed sputum aspirating device for the patients with intractable neurological disease using tracheotomy positive pressure ventilation (TPPV) in long-term care bed.
Scientific Title:Acronym
Effects of automated sputum aspirating device.
Region
| Japan |
Condition
Condition
intractable neurological disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of automated sputum aspirating device for the patients with intractable neurological diseases using tracheotomy positive pressure ventilation (TPPV) staying in long-term care bed.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The value of SpO2, the number of times of respiratory tract infection, the frequency of manual suctioning, and the expense of manual suctioning are evaluated before and after conducting automated sputum aspirating device for three months each other. SF8, a scale of health related quality of life is also measured.
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
automed sputum aspirating device
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Duchenn myscular dystrophy, Myotonic dystrophy type 1, Fukuyama congenital muscular dystrophy, Amyotrophic lateral sclerosis, multiple system atrophy
Currently hospitalized
using tracheotomy positive pressure ventilation 24 hours a day
capable of using switch for nurse call
twenty and above
the study carried out with the informed consent of the patient
Key exclusion criteria
A fever over 38 degree celsius
Count of leukocyte over 12,000 within 7 days before starting the study
Use antibiotics within 7 days before starting the study
The decrease of inspiratory pressure is less than 2 hPa after moving the device
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayasu Fukudome |
Organization
Nagasaki Kawatana Medical Center
Division name
Division of clinical medicine
Zip code
Address
2005-1 Shimogumigo Kawtanamachi Higashisonogigunn Nagasaki
TEL
0956823121
ereking@mua.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayasu Fukudome |
Organization
Nagasaki Kawatana Medical Center
Division name
Division of clinical medicine
Zip code
Address
2005-1 Shimogumigo Kawtanamachi Higashisonogigunn Nagasaki
TEL
0956823121
Homepage URL
ereking@mua.biglobe.ne.jp
Sponsor or person
Institute
Nagasaki Kawatana Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organizaition
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
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 | 09 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 31 | 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 | 09 | Month | 29 | Day |
Last modified on
| 2015 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017776
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
