UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048534 |
|---|---|
| Receipt number | R000055277 |
| Scientific Title | Study to reduce complications related to BIS sensor |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/02/01 11:31:45 |
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Basic information
Public title
Study to reduce complications related to BIS sensor
Acronym
Study to reduce complications related to BIS sensor
Scientific Title
Study to reduce complications related to BIS sensor
Scientific Title:Acronym
Study to reduce complications related to BIS sensor
Region
| Japan |
Condition
Condition
General anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The BIS quattro sensor reduces electrical resistance, which is an obstacle to EEG recording, by embedding the spine electrode within the stratum corneum of the forehead area through compression. On the other hand, depending on the magnitude of the compression force, it may cause pain during compression and postoperative skin lesions. The minimum compression force that sufficiently reduces electrical resistance is to be verified.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Electrical resistance after pressure on the BIS electrodes.
Key secondary outcomes
The success rate of impedance checks.
Pain during electrode compression.
Incidence of skin lesions.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention is to press the electrodes of the BIS quatro sensor. Perform with different pressure forces for each of the four groups.
In the first group, 5 Newton.
Interventions/Control_2
Intervention is to press the electrodes of the BIS quatro sensor. Perform with different pressure forces for each of the four groups.
In the second group, 10 Newton.
Interventions/Control_3
Intervention is to press the electrodes of the BIS quatro sensor. Perform with different pressure forces for each of the four groups.
In the third group, 15 Newton.
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 who are scheduled to undergo surgery under general anesthesia.
Key exclusion criteria
Patients with skin disorders on the forehead or suspected skin fragility on the forehead
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | Shuhei |
| Middle name | |
| Last name | Matsui |
Organization
Ina central hospital
Division name
Anesthesiology
Zip code
396-8555
Address
1313-1 Koshiroukubo, Ina-shi, Nagano-ken 396-8555 Japan
TEL
0265-72-3121
matsuimagawa@gmail.com
Public contact
Name of contact person
| 1st name | Shuhei |
| Middle name | |
| Last name | Matsui |
Organization
Ina central hospital
Division name
Anesthesiology
Zip code
396-8555
Address
1313-1 Koshiroukubo, Ina-shi, Nagano-ken 396-8555 Japan
TEL
0265-72-3121
Homepage URL
matsuimagawa@gmail.com
Sponsor or person
Institute
Ina central hospital
Institute
Department
Personal name
Funding Source
Organization
Ina central 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
Ina central hospital
Address
1313-1 Koshiroukubo, Ina-shi, Nagano-ken 396-8555 Japan
Tel
0265-72-3121
matsuimagawa@gmail.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
| 2024 | Year | 08 | 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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 07 | 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
| 2022 | Year | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055277
