UMIN-CTR Clinical Trial

Basic information
Public title	Development and validation of system to predict risk of complications
Acronym	Development and validation of system to predict risk of complications
Scientific Title	Development and validation of system to predict risk of complications
Scientific Title:Acronym	Development and validation of system to predict risk of complications
Region	Japan

Condition
Condition	Aspiration pneumonia
Classification by specialty	Pneumology Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effectiveness of patient care using artificial intelligence to control complications in hospitalized patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of patients with onset of aspiration pneumonia before and after the demonstration experiment
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	Each of the following are performed three times a day: *Enhanced oral care *Increasing the angle of the bed *Breathing training *Training on the intra-abdominal pressure *Postural change
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients hospitalized for 4 days or more
Key exclusion criteria	Patients hospitalized within 3 days
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Teppei Middle name Last name Shimizu
Organization	Kitahara International Hospital
Division name	Department of Pharmacy
Zip code	192-0045
Address	1-7-23, Owada-machi, Hachioji, Tokyo
TEL	042-645-1110
Email	teppei_shimizu@kitaharahosp.com

Public contact
Name of contact person	1st name Teppei Middle name Last name Shimizu
Organization	Kitahara International Hospital
Division name	Department of Pharmacy
Zip code	192-0045
Address	1-7-23, Owada-machi, Hachioji, Tokyo
TEL	042-645-1110
Homepage URL
Email	teppei_shimizu@kitaharahosp.com

Sponsor
Institute	Kitahara International Hospital
Institute
Department

Funding Source
Organization	Kitahara International Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	NEC Corporation
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kitahara International Hospital
Address	1-7-23, Owada-machi, Hachioji, Tokyo
Tel	042-645-1110
Email	jun_nagai@kitaharahosp.com

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	2019 Year 08 Month 26 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	2019 Year 04 Month 26 Day
Date of IRB	2019 Year 06 Month 01 Day
Anticipated trial start date	2019 Year 05 Month 13 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 09 Day
Last modified on	2020 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041607