UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029557 |
|---|---|
| Receipt number | R000033655 |
| Scientific Title | Smart Hospital : IoT service model empirical study for improvement on medical service |
| Date of disclosure of the study information | 2017/10/31 |
| Last modified on | 2018/01/20 14:34:42 |
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Basic information
Public title
Smart Hospital : IoT service model empirical study for improvement on medical service
Acronym
Smart Hospital : IoT service model empirical study
Scientific Title
Smart Hospital : IoT service model empirical study for improvement on medical service
Scientific Title:Acronym
Smart Hospital : IoT service model empirical study
Region
| Japan |
Condition
Condition
An inpatient
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Psychosomatic Internal Medicine | Infectious disease |
| Geriatrics | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Chest surgery |
| Endocrine surgery | Breast surgery | Obstetrics and Gynecology |
| Pediatrics | Ophthalmology | Dermatology |
| Psychiatry | Oto-rhino-laryngology | Orthopedics |
| Urology | Radiology | Anesthesiology |
| Oral surgery | Neurosurgery | Cardiovascular surgery |
| Plastic surgery | Aesthetic surgery | Laboratory medicine |
| Operative medicine | Emergency medicine | Blood transfusion |
| Intensive care medicine | Rehabilitation medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy of applying IoT devices on an infusion pump and to notice an alert to
nurses near the patient immediately, and compare the difference between with/without alert
notification to medical staff.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire
Error ratio
Scoring with a bigdata analyzation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Analytic result from the system will not
be delivered to the medical staffs through an
internet, though conventional pump alarm sound will be remain available.
Interventions/Control_2
Analytic result from the system (an alert from an infusion pump) will be delivered to the medical staffs through an internet.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
*inpatient (now or under the plan of) in Nagoya Univ hospital
*patient having a continuous drug infusion therapy or patient that can wear the prepared wristband medical device.
Key exclusion criteria
The patient;
*that does not communicate
*that cannot stay calm
*that might do harm to the device
*that has pacemakers or any medical devices that might have an effect on radiowaves
*that the control team decided unacceptable
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shintaro Oyama |
Organization
Nagoya Univ. Hospital
Division name
Medical IT center
Zip code
Address
Nagoya cty Showa-ku Tsurumaicho 65
TEL
052-744-1977
sooyama-ngy@umin.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KIMIKO NISHIMURA |
Organization
Nagoya Univ. Hospital
Division name
Medical IT center
Zip code
Address
Nagoya cty Showa-ku Tsurumaicho 65
TEL
052-744-1977
Homepage URL
sooyama-ngy@umin.jp
Sponsor or person
Institute
Nagoya Univ
Institute
Department
Personal name
Funding Source
Organization
Nagoya Univ
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
SATO Healthcare co.,ltd.,
NTT Data co.,ltd.,
CISCO
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 15 | Day |
Last modified on
| 2018 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033655
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
