UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019952 |
|---|---|
| Receipt number | R000023013 |
| Scientific Title | Efficacy study of the smart bed system |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2018/01/17 09:52:31 |
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Basic information
Public title
Efficacy study of the smart bed system
Acronym
Efficacy study of the smart bed system
Scientific Title
Efficacy study of the smart bed system
Scientific Title:Acronym
Efficacy study of the smart bed system
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of using the smart bed system in hospital
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The proportion of A to B
A: Cases that nurses catch medical events of patients
B: Cases that the smart bed system detects abnormalities of pulse rate and/or respiratory rate of patients
Key secondary outcomes
1. The proportion of A to B
A: Cases that nurses catch medical events of patients and do intervention (such as treatment, cure or care)
B: Cases that the smart bed system detects abnormalities of pulse rate and/or respiratory rate of patients
2. The proportion of A to B
A: Cases that no medical events of patients are observed
B: Cases that the smart bed system detects abnormalities of pulse rate and/or respiratory rate of patients
3. The proportion of cases that the pulse rate and respiratory rate monitoring on the smart bed system fails to detect severe events of patients
4. The time from A to B
A: Detection of abnormalities of pulse rate and/or respiratory rate of patients on the smart bed system
B: Catching of medical events of patients by nurses
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Using the smart bed system
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. in hospital patients at investigational ward
2. written or oral informed consent
Key exclusion criteria
1. less than 6 years old
2. patients who are judged to be inappropriate for this study by the attending doctor
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeuchi Reiko |
Organization
Saku Central Hospital
Division name
Department of nursing
Zip code
Address
197 Usuda,Saku,Nagano
TEL
0267-82-3131
kango@sakuhp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nagaoka Hiroshi |
Organization
PARAMOUNT BED CO., LTD.
Division name
Research and development department
Zip code
Address
2-14-5 Higashisuna,Koto-ku,Tokyo
TEL
03-3648-1305
Homepage URL
h.nagaoka@paramount.co.jp
Sponsor or person
Institute
PARAMOUNT BED CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
PARAMOUNT BED CO., LTD.
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
Address
Tel
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
佐久総合病院（長野県) , 佐久総合病院佐久医療センター（長野県）
Saku Central Hospital , Saku Central Hospital Advanced Care Center
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 08 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 27 | Day |
Last modified on
| 2018 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023013
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
