UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049613 |
|---|---|
| Receipt number | R000056308 |
| Scientific Title | Study on the application of BIS Quattro Sensors |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/11/26 09:27:44 |
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Basic information
Public title
Study on the application of BIS Quattro Sensors
Acronym
Study on the application of BIS Quattro Sensors
Scientific Title
Study on the application of BIS Quattro Sensors
Scientific Title:Acronym
Study on the application of BIS Quattro Sensors
Region
| Japan |
Condition
Condition
General anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impedance change, impedance check clearance rate, pain during compression, and incidence of skin disorders when the BIS QuattroSensor is applied and compressed on the patient by anesthesiologists in the usual procedure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
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
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention is to press the electrodes of the BIS quatro sensor. The compression force is based on the subjective feelings of anesthesiologists as usual practice.
Interventions/Control_2
Intervention is to press the electrodes of the BIS quatro sensor. The compression force is based on the subjective feelings ofanesthesiologists who are trained to compress at 10N.
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 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
42
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
0265723121
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
| 2024 | Year | 11 | Month | 26 | Day |
Date trial data considered complete
| 2024 | Year | 11 | Month | 26 | Day |
Date analysis concluded
| 2024 | Year | 11 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 25 | Day |
Last modified on
| 2024 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056308
