UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043764 |
|---|---|
| Receipt number | R000049961 |
| Scientific Title | Development of a Prediction System for Analgesic Effects and Diaphragmatic Paralysis of Brachial Plexus Block Using Artificial Intelligence |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2023/12/08 18:15:50 |
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Basic information
Public title
Development of a Prediction System for Analgesic Effects and Diaphragmatic Paralysis of Brachial Plexus Block Using Artificial Intelligence
Acronym
Development of a Prediction System for Analgesic Effects and Diaphragmatic Paralysis of Brachial Plexus Block Using Artificial Intelligence
Scientific Title
Development of a Prediction System for Analgesic Effects and Diaphragmatic Paralysis of Brachial Plexus Block Using Artificial Intelligence
Scientific Title:Acronym
Development of a Prediction System for Analgesic Effects and Diaphragmatic Paralysis of Brachial Plexus Block Using Artificial Intelligence
Region
| Japan |
Condition
Condition
Rotator cuff tear
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aim is to develop a system to predict analgesic effect and the probability of diaphragmatic paralysis from ultrasound images during brachial plexus block.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prediction accuracy (sensitivity, specificity, and area under the curve) of postoperative analgesic effect and presence of diaphragmatic paralysis (sensitivity, specificity, and prediction accuracy) in the created system.
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Preoperative and postoperative ultrasonography to diagnose diaphragmatic paralysis.
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
Patients undergoing rotator cuff tear surgery with brachial plexus block
Key exclusion criteria
Patients with respiratory dysfunction or asthma
Patients with anatomical abnormalities in the upper limbs
Patients who did not give consent for the study
Cases in which the operation time exceeds 4 hours
Patients undergoing emergency surgery
Patients with preoperative diaphragmatic paralysis
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Kuroki |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
990-9585
Address
2-2-2 Iida-nishi, Yamagata city, Yamagata 990-9585, Japan
TEL
023-628-5400
m_kuroki@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Kuroki |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
990-9585
Address
2-2-2 Iida-nishi, Yamagata city, Yamagata 990-9585, Japan
TEL
023-628-5400
Homepage URL
m_kuroki@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Yamagata University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
the Japan Society for the Promotion of Science KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yoshioka Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethical Review Committee of Yamagata University Faculty of Medicine
Address
2-2-2, Iida-nishi, yamagata city, Yamagata japan
Tel
023-628-5015
ikekenkyu@jm.kj.yamagata-u.ac.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
山形大学医学部附属病院(山形県)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 03 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049961
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
