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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029557
Receipt No. 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

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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 Obsterics 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
Email 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
Email sooyama-ngy@umin.jp

Sponsor
Institute Nagoya Univ
Institute
Department

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
Email

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
URL(English) https://upload.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


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