UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043764
Receipt No. 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 2021/04/18

* 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 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 5 hours
Patients undergoing emergency surgery
Patients with preoperative diaphragmatic paralysis
Target sample size 100

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
Email 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
Email m_kuroki@med.id.yamagata-u.ac.jp

Sponsor
Institute Department of Anesthesiology, Yamagata University Faculty of Medicine
Institute
Department

Funding Source
Organization Department of Anesthesiology, Yamagata University Faculty of Medicine
Organization
Division
Category of Funding Organization Self funding
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
Email 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 Preinitiation
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
2021 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049961

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.