UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038900 |
|---|---|
| Receipt number | R000042280 |
| Scientific Title | Agreement of respiratory rate monitoring with microwave Doppler sensor below the bed |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2023/10/06 00:59:48 |
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Basic information
Public title
Agreement of respiratory rate monitoring with microwave Doppler sensor below the bed
Acronym
Agreement of respiratory rate monitoring with microwave Doppler sensor below the bed
Scientific Title
Agreement of respiratory rate monitoring with microwave Doppler sensor below the bed
Scientific Title:Acronym
Agreement of respiratory rate monitoring with microwave Doppler sensor below the bed
Region
| Japan |
Condition
Condition
Spontaneous breathing patients who received oxygen supplementation at intensive care unit
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the agreement of respiratory rate measurement with microwave Doppler sensor below the bed
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate bias and 95% limits of agreement of respiratory rate measurements between microwave Doppler sensor below the bed and Capnography
Key secondary outcomes
1) To evaluate bias and 95% limits of respiratory rate measurements between Pressure sensor and Capnography
2) To evaluate bias and 95% limits of respiratory rate measurements between microwave Doppler sensor below the bed/Pressure sensor and Visual counting
3) To evaluate bias and 95% limits of respiratory rate measurements between Capnography and Electrical thoracic impedance
4) Incidence rate affecting respiratery rate measurements by each devices(microwave Doppler sensor, Capnography, and Electrical thoracic impedance)
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) Over 20 years old
2) Postoperative patients who enter to the intensive care unit of Yokohama City University Hospital
3) Patients who need oxygen supplementation via the nasal cannula
4) Patients who were obtained informed consents of this study
Key exclusion criteria
1) Patients who were not obtained informed consents of this study
2) Patients with the interstitial pneumonia
3) Patients with Sleep apnea syndrome
4) Inappropriate case by research director's judgement
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Takaki |
Organization
Yokohama City University Hospital
Division name
Department of Anesthesiology and Critical Care
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
+81457872800
shunty5323@gmail.com
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tanaka |
Organization
Yokohama City University 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
http://www.yokohama-cu.ac.jp/fukuhp/
tanaka@nms.ac.jp
Sponsor or person
Institute
Yokohama City University, 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
Japan
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
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
doi: 10.1007/s10877-023-01081-7.
Publication of results
Published
Result
URL related to results and publications
doi: 10.1007/s10877-023-01081-7.
Number of participants that the trial has enrolled
24
Results
Eighteen participants were included. The bias (95% limits of Agreement) of the microwave Doppler sensor, thoracic impedance pneumography, and piezoelectric sensor were 0.2 (-4.8 to 5.2), 1.5 (-4.4 to 7.4), and 0.4 (-4.0 to 4.8) breaths/minute, respectively.
Results date posted
| 2023 | Year | 10 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median [interquartile range] values of age and body mass index of analyzed participants were 57.5[48.3 - 60.6] years and 22.8 [21.9 - 24.4] kg/m2, respectively.
Participant flow
Respiratory rates were measured for participants admitted to the intensive care units after surgery by microwave Doppler sensor, capnography, thoracic impedance pneumography, piezoelectric sensors, and visual counting.
Adverse events
This observational study did not assess any adverse events as a protocol.
Outcome measures
Primary outcome was that the bias (95% limits of Agreement) of the microwave Doppler sensor, thoracic impedance pneumography, and piezoelectric sensor were 0.2 (-4.8 to 5.2), 1.5 (-4.4 to 7.4), and 0.4 (-4.0 to 4.8) breaths/minute, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Methods:
1) We simultaneously measure respiratory rate by Microwave Doppler sensor, Pressure sensor, Capnography and Electrical thoracic impedance.
One measurment period is defined as continuous 15 minutes. Measurment period is planed to performe at least twice during the night time(1:00 to 6:00).
Therefore, we will obtain 30 data points per patients, at least.
2) visual counting
We measure respiratory rate by visual counting once per hour as usual clinical work of the incharge nurse.
Management information
Registered date
| 2019 | Year | 12 | Month | 16 | Day |
Last modified on
| 2023 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042280
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