UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047839 |
|---|---|
| Receipt number | R000054540 |
| Scientific Title | Examination of the reliability of technology for detecting heart rate and respiratory rate using a non-contact Doppler sensor |
| Date of disclosure of the study information | 2022/05/24 |
| Last modified on | 2024/06/11 10:19:53 |
* 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
Examination of the reliability of technology for detecting heart rate and respiratory rate using a non-contact Doppler sensor
Acronym
Examination of the reliability of technology for detecting heart rate and respiratory rate using a non-contact Doppler sensor
Scientific Title
Examination of the reliability of technology for detecting heart rate and respiratory rate using a non-contact Doppler sensor
Scientific Title:Acronym
Examination of the reliability of technology for detecting heart rate and respiratory rate using a non-contact Doppler sensor
Region
| Japan |
Condition
Condition
Patients in a high care unit
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine whether a non-contact Doppler sensor can be used to measure a patient's vital signs.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heartbeat count, heartbeat interval, breath count
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Non-trauma patients aged 20 years or older admitted to the HCU of the Department of Emergency Medicine at Keio University Hospital
2) Patients who understand the content of this study and are capable of obtaining written consent or consent by a substitute.
Key exclusion criteria
1) The patient is likely to leave the HCU within 24 hours of the start of measurement with the non-contact sensor.
2) If the bedside monitor is not attached or is likely to be removed within 24 hours of the measurement with the non-contact sensor.
3) The principal investigator or subinvestigator determines that the subject is not appropriate for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Homma |
Organization
Keio University, school of medicine
Division name
Emergency and Critical Care Medicine
Zip code
1608582
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
0333531211
homma@keio.jp
Public contact
Name of contact person
| 1st name | KOICHIRO |
| Middle name | |
| Last name | HOMMA |
Organization
Keio University, school of medicine
Division name
Emergency and Critical Care Medicine
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
0333531211
Homepage URL
homma@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
SEKISUI HOUSE
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi Shinjuku-ku Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.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
| 2022 | Year | 05 | Month | 24 | 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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2022 | Year | 05 | Month | 24 | Day |
Last modified on
| 2024 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054540
