UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050334 |
|---|---|
| Receipt number | R000057153 |
| Scientific Title | Change characteristics of the high frequency variability index (HFVI) in patients receiving ultrasound-guided peripheral nerve block |
| Date of disclosure of the study information | 2023/02/28 |
| Last modified on | 2024/04/23 09:49:28 |
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Basic information
Public title
Change characteristics of the high frequency variability index (HFVI) in patients receiving ultrasound-guided peripheral nerve block
Acronym
Change characteristics of the high frequency variability index (HFVI) in patients receiving ultrasound-guided peripheral nerve block
Scientific Title
Change characteristics of the high frequency variability index (HFVI) in patients receiving ultrasound-guided peripheral nerve block
Scientific Title:Acronym
Changes of the high frequency variability index (HFVI) in ultrasound-guided peripheral nerve block
Region
| Japan |
Condition
Condition
patients recieving the upper limb surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate whether the High Frequency Variability Index(HFVI) can be used as an indicator of efficacy of the ultrasound-guided brachial plexus blocks (USBPB) by revealing the effect of effective USBPB on HFVI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the changes of HFVI after USBPB
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients undergoing the orthopaedic upper limb surgery
Key exclusion criteria
the patients with serious cardiovascular dosease, who are American Society of Anestheologists physical status class 3 or more, who are administered an anticholinergic agent,with arrhythmia or implanted pacemaker and inappropriate recordind of HFVI.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | MOTOI |
| Middle name | |
| Last name | KUMAGAI |
Organization
Iwate medical university hospital
Division name
Department of Anesthesiology
Zip code
028-3695
Address
2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
TEL
019-613-7111
motoij@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | MOTOI |
| Middle name | |
| Last name | KUMAGAI |
Organization
Iwate medical university hospital
Division name
Department of Anesthesiology
Zip code
028-3695
Address
2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
TEL
019-613-7111
Homepage URL
motoij@iwate-med.ac.jp
Sponsor or person
Institute
Iwate medical university hospital
Institute
Department
Personal name
Funding Source
Organization
Iwate medical university hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate medical university hospital
Address
2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
Tel
019-613-7111
motoij@iwate-med.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 28 | 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
| 2023 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 22 | 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
observational study
Management information
Registered date
| 2023 | Year | 02 | Month | 14 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057153
