UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049295 |
|---|---|
| Receipt number | R000056144 |
| Scientific Title | Study on the Position of Stimulation Electrode during Electromyographic Muscle Relaxation Monitoring Using the NIHON KOHDEN AF201-P and NM-34: Comparison of Measurement Accuracy in Supination and Pronation of the Measured Upper Limb |
| Date of disclosure of the study information | 2022/10/24 |
| Last modified on | 2024/09/04 15:01:26 |
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Basic information
Public title
Study on the Position of Stimulation Electrode during Electromyographic Muscle Relaxation Monitoring Using the NIHON KOHDEN AF201-P and NM-34: Comparison of Measurement Accuracy in Supination and Pronation of the Measured Upper Limb
Acronym
Study on the Position of Stimulation Electrode during Electromyographic Muscle Relaxation Monitoring Using the NIHON KOHDEN AF201-P and NM-34: Comparison of Measurement Accuracy in Supination and Pronation of the Measured Upper Limb
Scientific Title
Study on the Position of Stimulation Electrode during Electromyographic Muscle Relaxation Monitoring Using the NIHON KOHDEN AF201-P and NM-34: Comparison of Measurement Accuracy in Supination and Pronation of the Measured Upper Limb
Scientific Title:Acronym
Study on the Position of Stimulation Electrode during Electromyographic Muscle Relaxation Monitoring Using the NIHON KOHDEN AF201-P and NM-34: Comparison of Measurement Accuracy in Supination and Pronation of the Measured Upper Limb
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The recommended application position of the electromyography electrode sticker (NM-34) in electromyography-based muscle relaxation monitoring using the muscle relaxation module (AF-201P) of NIHON KOHDEN Corporation is to overlap the corner of the stimulating electrode on the bean bone and to apply it along the ulnar nerve. However, accurate monitoring was not always possible when the upper limb was placed along the side of the body or during surgery in a supine or prone position. The purpose of this study is to examine the position of the stimulating electrode that does not decrease measurement accuracy when the upper limb is in supination and pronation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Stimulation current value at calibration
Key secondary outcomes
T1 value by TOF (train-of-four: four consecutive stimulations) 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
Healthy adults
Key exclusion criteria
Persons with neuropathy or neuromuscular disease
Patients with pacemakers or implantable cardioverter-defibrillators
Persons with fragile skin at the measurement site
Patients with a history of surgery on the measurement limb
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Kaneko |
Organization
Nagasaki University Hospital
Division name
Department of Anesthesiology
Zip code
852-8102
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7370
s-kaneko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Kaneko |
Organization
Nagasaki University Hospital
Division name
Department of Anesthesiology
Zip code
852-8102
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7370
Homepage URL
s-kaneko@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Nagasaki University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences
Address
1-12-4 Sakamoto, Nagasaki
Tel
095-819-7198
gakujutu_gakuji@ml.nagasaki-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
長崎大学病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 24 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00540-023-03250-z
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00540-023-03250-z
Number of participants that the trial has enrolled
28
Results
Crossing the ulnar nerve with the line connecting the anode and cathode of the stimulating electrodes may stabilize EMG-based neuromuscular monitoring accuracy.
Results date posted
| 2024 | Year | 09 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The protocol was followed.
Participant flow
The protocol was followed.
Adverse events
None.
Outcome measures
The protocol was followed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 18 | Day |
Other
Other related information
The ulnar nerve in the participant's forearm will be identified with an ultrasound device and marked on the skin. Calibration and TOF measurement will be performed with the following three attachment methods per participant in the study to compare the accuracy of muscle relaxation monitoring by stimulating electrode position.
(1) Stimulation electrode placement recommended by NIHON KOHDEN
(2) Place the stimulating electrode directly above the ulnar nerve
(3) Place the ulnar nerve between the cathode and anode of the stimulating electrode
Stimulation current values by calibration and T1 values by TOF measurement are measured at 3 positions of 90 degrees in supination, 0 degrees, and 90 degrees in pronation for each attachment method.
Management information
Registered date
| 2022 | Year | 10 | Month | 24 | Day |
Last modified on
| 2024 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056144
