UMIN-CTR Clinical Trial

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
Email	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
Email	tjsaitoh@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046439