UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040702 |
|---|---|
| Receipt number | R000046439 |
| Scientific Title | Breathe-Recognition Using a Small Drone in Disaster Sites |
| Date of disclosure of the study information | 2020/06/11 |
| Last modified on | 2020/12/09 13:04:26 |
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Basic information
Public title
Breathe-Recognition Using a Small Drone in Disaster Sites
Acronym
Breathe-Recognition Using a Small Drone in Disaster Sites
Scientific Title
Breathe-Recognition Using a Small Drone in Disaster Sites
Scientific Title:Acronym
Breathe-Recognition Using a Small Drone in Disaster Sites
Region
| Japan |
Condition
Condition
Respiratory arrest (simulation)
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate whether a camera of a small drone can detect the respiration, when the drone lands on the abdomen or when the drone is on flight.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The accuracy to detect whether subjects breathe or not through the drone camera on the abdomen
Key secondary outcomes
The accuracy to detect whether subjects breathe or not through the drone camera on the back
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
We evaluate whether subjects breathe or not through a drone camera, after the small drone lands on the abdomen of subjects.
Interventions/Control_2
We evaluate whether subjects breathe or not through a drone camera, when the drone is on flight.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women equal to and over 20 years old
Key exclusion criteria
Pregnant women and subject with mental diseases
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Takeji |
| Middle name | |
| Last name | Saitoh |
Organization
Hamamatsu University School of Medicine
Division name
Department of Emergency & Disaster Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL
053-435-2759
tjsaitoh@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takeji |
| Middle name | |
| Last name | Saitoh |
Organization
Hamamatsu University School of Medicine
Division name
Department of Emergency & Disaster Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL
053-435-2759
Homepage URL
tjsaitoh@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
Tel
053-435-2680
rinri@hama-med.ac.jp
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
| 2020 | Year | 06 | Month | 11 | 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
46
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
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 10 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 20 | Day |
Date analysis concluded
| 2020 | Year | 11 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 09 | Day |
Last modified on
| 2020 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046439
