UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory observational study: Continuous body weight monitoring with load cell sensor-Development of measurement algorithm for perioperative patients
Acronym	Continuous body weight monitoring with load cell sensor
Scientific Title	Exploratory observational study: Continuous body weight monitoring with load cell sensor-Development of measurement algorithm for perioperative patients
Scientific Title:Acronym	Continuous body weight monitoring with load cell sensor
Region	Japan

Condition
Condition	elective surgical patients
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Development of measurement algorithm for weight change in surgical patients
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body weight change before and after surgery
Key secondary outcomes	Correlation between intraoperative weight changes and intraoperative fluid volume,Change in body weight from the next day after surgery until discharge,Respiratry rate, heart rate, sleep and awakeing rhythm

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	elective surgical patient under general anesthesia at Chiba University Hospital
Key exclusion criteria	1.minor 2.emergency surgery 3.patient with data loss 4.Patients who are judged inappropriate by the principal investigator
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kyongsuk Middle name Last name Son
Organization	Department of Anesthesiology
Division name	Anesthesiology
Zip code	260-8677
Address	1-8-1 inohana chuuou-ku chiba-shi
TEL	043-222-7171
Email	kyong0203suk@yahoo.co.jp

Public contact
Name of contact person	1st name Kyongsuk Middle name Last name Son
Organization	Department of Anesthesiology
Division name	Anesthesiology
Zip code	260-8677
Address	1-8-1 inohana chuuou-ku chiba-shi
TEL	043-222-7171
Homepage URL
Email	kyong0203suk@yahoo.co.jp

Sponsor
Institute	Chiba university
Institute
Department

Funding Source
Organization	MinebeaMitsumi Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Committee of chiba university
Address	1-8-1 inohana chuuou-ku chiba-shi
Tel	043-222-7171
Email	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	千葉大学医学部附属病院（千葉県）

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 15 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	20
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 11 Month 28 Day
Date of IRB	2019 Year 11 Month 28 Day
Anticipated trial start date	2019 Year 12 Month 16 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded

Other

Other related information

The bed sensor monitor information records information on respiratory rate, heart rate, body weight and sleep and awakeing rhythm from preoperative to discharge. There are no restrictions on the infusion method on the day of surgery. We use infusion methods appropriate for the patient. Anesthesia and vasopressor use should be appropriate for the patient. Patients will continue to be monitored by a non-contact bed sensor from the day before surgery until the date of discharge.

Management information
Registered date	2020 Year 04 Month 15 Day
Last modified on	2021 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044319