UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013728 |
|---|---|
| Receipt number | R000016027 |
| Scientific Title | Assessment of coordination between breathing and swallowing during noninvasive positive pressure ventilation |
| Date of disclosure of the study information | 2014/05/15 |
| Last modified on | 2019/10/19 10:57:18 |
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Basic information
Public title
Assessment of coordination between breathing and swallowing during noninvasive positive pressure ventilation
Acronym
Assessment of coordination between breathing and swallowing during noninvasive positive pressure ventilation
Scientific Title
Assessment of coordination between breathing and swallowing during noninvasive positive pressure ventilation
Scientific Title:Acronym
Assessment of coordination between breathing and swallowing during noninvasive positive pressure ventilation
Region
| Japan |
Condition
Condition
Patients with chronic respiratory failure
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of coordination between breathing and swallowing during noninvasive positive pressure ventilation
Basic objectives2
Others
Basic objectives -Others
Assessment of coordination between breathing and swallowing during noninvasive positive pressure ventilation
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Coordination between breathing and swallowing
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic respiratory failure under the control of noninvasive positive pressure ventilation due to exacerbation
Key exclusion criteria
Those who are judged by a doctor as inappropriate candidates
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Oku |
Organization
Hyogo College of Medicine
Division name
Division of Physiome, Department of Medicine
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
0798-45-6385
yoku@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Oku |
Organization
Hyogo College of Medicine
Division name
Division of Physiome, Department of Medicine
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
0798-45-6385
Homepage URL
yoku@hyo-med.ac.jp
Sponsor or person
Institute
Kyoto University Hospital Clinical Research Center for Medical Equipment Development
Institute
Department
Personal name
Funding Source
Organization
J Craft Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
星ヶ丘厚生年金病院（大阪府）、北野病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 15 | 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
Main results already published
Date of protocol fixation
| 2013 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Swallowing states are monitored using a non-invasive swallowing activity monitoring and analysis system that recognizes swallowing and assesses swallowing function by analyzing relationships among swallowing sound, laryngeal motion, and respiration.
Measurements are done at three periods: 1. the period when noninvasive positive pressure ventilation is initiated (at least 24 hours after the initiation), 2. the period when the patient is able to be weaned from the ventilator for more than one hour, 3. the period when the patient is able to be weaned from the ventilator completely.
Management information
Registered date
| 2014 | Year | 04 | Month | 16 | Day |
Last modified on
| 2019 | 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=R000016027
