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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032021
Receipt No. R000035444
Scientific Title Accuracy of respiratory rate monitoring measured using a microwave doppler senser
Date of disclosure of the study information 2018/03/30
Last modified on 2019/01/24

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Basic information
Public title Accuracy of respiratory rate monitoring measured using a microwave doppler senser
Acronym Accuracy of respiratory rate monitoring measured using a microwave doppler senser
Scientific Title Accuracy of respiratory rate monitoring measured using a microwave doppler senser
Scientific Title:Acronym Accuracy of respiratory rate monitoring measured using a microwave doppler senser
Region
Japan

Condition
Condition Natural airway patients at intensive care units
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the usefulness of respiratory rate monitoring of ceiling installed type microwave doppler senser.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison with the accuracy of the respiratory rate measured using a microwave doppler sensor and that measured by actual measurement values
Key secondary outcomes Comparison of accuracy of respiratory rate between actual measurement values and following two methods; i.e. thoracic impedance method and capno monitoring method

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) Patients who are over 20 years old
(2) Patients who entered following intensive care units (i.e. Yokohama City University Hospital intensive care unit, Yokohama Municipal Stroke/Neurological Center intensive care unit)
(3) Patients who were obtained consents of this study
Key exclusion criteria (1) Patients who were not obtained consents of this study
(2) Patients undergoing respiratory management by ventilator
(3) Patients who were judged as an unsuitable subject by the research director
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Takaki
Organization Yokohama City Universty Hospital
Division name Department of Anesthesiology and Critical Care
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL +81457872800
Email shunty5323@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Tanaka
Organization Yokohama City Universty Hospital
Division name Department of Anesthesiology and Critical Care
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL +81457872800
Homepage URL https://www.yokohama-cu.ac.jp/fukuhp/
Email tanaka@nms.ac.jp

Sponsor
Institute Yokohama City Universty, Department of Anesthesiology and Critical Care
Institute
Department

Funding Source
Organization KONICA MINOLTA, INC.
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
Address
Tel
Email

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 横浜市立大学附属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 30 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Methods:
1)Patients background is investigated and collected from patients' medical records at the time of case registration.
2)Data collection
A charge nurse measures the number of the movement of patients' thorax for 1 minute, every 1 hour. This number is defined as actual measurement values (i.e. reference value).
The respiratory rate of the following three ways are recorded at the same time; a microwave doppler senser, capno monitoring method and thoracic impedance method.

3)Analysis methods
A)The correlation coefficients between each method are calculated by Spearman rank sum test.
B)Bland-Altman analysis for repeated measured is performed to calculate the Bias, precision and 95% limits of agreement between each respiratory rate measurements.
The interchangeability between the two methods defines pulse and minuse 3 breaths per minute.

Management information
Registered date
2018 Year 03 Month 30 Day
Last modified on
2019 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035444

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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