UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032021
Receipt number 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 2021/07/04 05:23:01

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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 Shunsuke
Middle name
Last name Takaki

Organization

Yokohama City Universty Hospital

Division name

Department of Anesthesiology and Critical Care

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan

TEL

+81457872800

Email

shunty5323@gmail.com


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Tanaka

Organization

Yokohama City Universty Hospital

Division name

Department of Anesthesiology and Critical Care

Zip code

236-0004

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 or person

Institute

Yokohama City Universty, Department of Anesthesiology and Critical Care

Institute

Department

Personal name



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

Yokohama City University, Department of Anesthesiology and Critical Care

Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan

Tel

+81457872800

Email

tanaka@nms.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

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

https://doi.org/10.1007/s10877-021-00733-w

Number of participants that the trial has enrolled

52

Results

Among 52 participants, there were 336 (microwave Doppler sensor), 275 (capnography), and 336 (thoracic impedance pneumography) paired respiratory rate data points. Bias (95% limits of agreement) estimates were as follows:
microwave Doppler sensor,0.3(-6.1 to 6.8)breaths/min; capnography, -1.3(-8.6 to 6.0)breaths/min; thoracic impedance pneumography, 0.1(-4.4 to 4.7)breaths/min.




Results date posted

2021 Year 07 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 06 Month 30 Day

Baseline Characteristics


Participant flow


Adverse events

None

Outcome measures

Outcomes were estimates of bias and 95%
limits of agreement between respiratory rates determined by visual counting and those determined using the microwave Doppler sensor, capnography and thoracic impedance pneumography, respectively.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2017 Year 12 Month 20 Day

Date of IRB

2017 Year 12 Month 20 Day

Anticipated trial start date

2018 Year 03 Month 30 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry

2021 Year 06 Month 30 Day

Date trial data considered complete

2021 Year 06 Month 30 Day

Date analysis concluded

2021 Year 06 Month 30 Day


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

2021 Year 07 Month 04 Day



Link to view the page

Value
https://center6.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