UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040164 |
|---|---|
| Receipt number | R000044319 |
| Scientific Title | Exploratory observational study: Continuous body weight monitoring with load cell sensor-Development of measurement algorithm for perioperative patients |
| Date of disclosure of the study information | 2020/04/15 |
| Last modified on | 2021/04/17 20:48:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kyong0203suk@yahoo.co.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044319
