UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048278 |
|---|---|
| Receipt number | R000055016 |
| Scientific Title | Evaluation of Muscle Volume on Ultrasound Image Analysis Using the Panoramic View Function in Critically Ill Patients: A single-center prospective observational study |
| Date of disclosure of the study information | 2022/07/06 |
| Last modified on | 2023/07/28 13:40:44 |
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Basic information
Public title
Evaluation of Muscle Volume on Ultrasound Image Analysis Using the Panoramic View Function in Critically Ill Patients: A single-center prospective observational study
Acronym
Evaluation of Muscle Volume on Ultrasound Image Analysis Using the Panoramic View Function in Critically Ill Patients: A single-center prospective observational study
Scientific Title
Evaluation of Muscle Volume on Ultrasound Image Analysis Using the Panoramic View Function in Critically Ill Patients: A single-center prospective observational study
Scientific Title:Acronym
Evaluation of Muscle Volume on Ultrasound Image Analysis Using the Panoramic View Function in Critically Ill Patients: A single-center prospective observational study
Region
| Japan |
Condition
Condition
critically ill patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of an ultrasound system with panoramic view function for the evaluation of muscle loss in the acute phase of a critically ill patient.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of ultrasound assessment of femoral muscle mass loss rate using the panoramic view function compared to CT assessment.
Key secondary outcomes
The relationship between the rate of thigh muscle loss on ultrasonography with the Panoramic View function and the PICS assessment on day 30.
Relationship between the percentage of thigh muscle loss on ultrasonography with the Panoramic View function and the assessment of physical function on day 30.
Intraclass correlation coefficient of ultrasound muscle mass measurement
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients admitted to our specific intensive care unit
(2) Patients who are 20 years of age or older at the time of obtaining consent
(3) Patients who have been fully informed about their participation in this study, and who have given written consent of their own or their representative's free will based on sufficient understanding.
Key exclusion criteria
(1) Young women under 35 years of age or considered fertile
(2) Patients who could not give consent
(3) Patients with serious fracture of the lower body, ASO of the lower extremity, or serious infection of the lower extremity
(iv) Patients with Extracorporeal Membrane Oxygenation (ECMO)
(5) Other patients deemed inappropriate as subjects by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ikechi |
Organization
Hitachi General Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
317-0077
Address
2-1-1 Jonancho, hitachi-shi, Ibaraki, Japan
TEL
08063191701
ikechi-ygc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ikechi |
Organization
Hitachi General Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
317-0077
Address
2-1-1 Jonancho, hitachi-shi, Ibaraki, Japan
TEL
0294231111
Homepage URL
ikechi-ygc@umin.ac.jp
Sponsor or person
Institute
Hitachi General Hospital
Institute
Department
Personal name
Funding Source
Organization
ZENKYOREN (National Mutual Insurance Federation of Agricultural Cooperatives)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Corporate Hospital Group, Hitachi, Ltd.
Address
2-1-1, Jonancho, Hitachi, Ibaraki, Japan
Tel
0294231111
masahiro.miura.cz@hitachi.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
| 2022 | Year | 07 | Month | 06 | 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
| 2022 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Research Design)
Cohort Study
(Eligible Patients)
All patients who entered our intensive care unit between July 15, 2022 and March 31, 2023, and were systemically managed by the emergency intensive care unit and met the selection criteria.
Management information
Registered date
| 2022 | Year | 07 | Month | 05 | Day |
Last modified on
| 2023 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055016
