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 2022/05/24 12:40:13

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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

Email

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


Email

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

Email

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

Open public recruiting

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

2022 Year 05 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054540


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name