UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030480 |
|---|---|
| Receipt number | R000034803 |
| Scientific Title | Bed Sensor vital-sign monitoring System with under-the-bed load cells-A trial for clinical use |
| Date of disclosure of the study information | 2017/12/22 |
| Last modified on | 2023/10/17 11:18:54 |
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Basic information
Public title
Bed Sensor vital-sign monitoring System with under-the-bed load cells-A trial for clinical use
Acronym
A clinical use of Bed Sensor System
Scientific Title
Bed Sensor vital-sign monitoring System with under-the-bed load cells-A trial for clinical use
Scientific Title:Acronym
A clinical use of Bed Sensor System
Region
| Japan |
Condition
Condition
Inpatients in Palliative Care Unit
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We have developed an integrated non-invasive contact-free vital-signs monitor with four load cells under the bed. This project aims to provide a system to allow all medical staff to utilize this bed sensor vital sign monitoring system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Early detection of patient abnormality
Key secondary outcomes
Reduction of medical staff burden
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
In-patients in Palliative Care Unit
Key exclusion criteria
None
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shiroh |
| Middle name | |
| Last name | Isono |
Organization
Chiba University
Division name
Graduate School of Medicine, Anesthesiology
Zip code
260-8670
Address
1-8-1 Inohana Chuo Chiba
TEL
043-226-2155
shirohisono@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Natsuko |
| Middle name | |
| Last name | Taguchi |
Organization
Chiba University
Division name
Graduate School of Medicine, Anesthesiology
Zip code
260-8670
Address
1-8-1 Inohana Chuo Chiba
TEL
043-226-2155
Homepage URL
nnoztag@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
MinebeaMitsumi Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University School of Medicine
Address
1-8-1 Inohan Chuo Chiba
Tel
043-222-7171
igaku-rinri@office.chiba-u.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
| 2017 | Year | 12 | Month | 22 | Day |
Related information
URL releasing protocol
https://journals.physiology.org/doi/full/10.1152/japplphysiol.00904.2020?rfr_dat=cr_pub++0pubmed&url
Publication of results
Published
Result
URL related to results and publications
https://journals.physiology.org/doi/full/10.1152/japplphysiol.00904.2020?rfr_dat=cr_pub++0pubmed&url
Number of participants that the trial has enrolled
120
Results
Respiratory rate was lower and breathing irregularity was higher in patients treated with opioids, throughout the day. We conclude that respiratory rhythm irregularities are the main feature of opioid dose-dependent respiratory depression, especially in female patients with advanced cancer.
Results date posted
| 2023 | Year | 10 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 06 | Month | 13 | Day |
Baseline Characteristics
Patients with advanced cancer hospitalized for palliative care (on opioid n=39, with no opioid n=12)
Participant flow
Patients were explained of the purpose and methods of the research and gave written informed consent
Adverse events
None
Outcome measures
Respiratory instability
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Direct questionnaire to the medical staff after the
development of the software.
Management information
Registered date
| 2017 | Year | 12 | Month | 20 | Day |
Last modified on
| 2023 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034803
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
