Status Approved
First Submitted Date
2020/12/10
Registered Date
2021/01/25
Last Updated Date
2021/01/10
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0005815 |
|---|---|
| Unique Protocol ID | k2020-1459-002 |
| Public/Brief Title | Clinical trials on the market for anesthesia depth meter |
| Scientific Title | Evaluation of depth of anesthesia using BIS and CAI system |
| Acronym | Bispectral Index → BIS, Cortical Activity Index→ CAI |
| MFDS Regulated Study | No |
| IND/IDE Protocol | No |
| Registered at Other Registry | No |
| Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
| Board Approval Status | Submitted approval |
|---|---|
| Board Approval Number | 2020AS0275 |
| Approval Date | 2020-10-06 |
| Institutional Review Board Name | Korea University Medicine Ansan Hospital Intstitutional Review Board |
| Institutional Review Board Address | 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do |
| Institutional Review Board Telephone | 031-412-6514 |
| Data Monitoring Committee | No |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Too Jae Min |
| Title | Dr |
| Telephone | +82-31-412-5285 |
| Affiliation | Korea University Ansan Hospital |
| Address | Korea University Ansan Hospital 123, Jeokgeum-ro, Danwongu, Ansan-si, Gyeonggi-do 15355 |
| Contact Person for Public Queries | |
| Name | Young sung Kim |
| Title | Dr |
| Telephone | +82-31-412-6716 |
| Affiliation | Koera University Guro Hospital |
| Address | 148, Gurodong-ro, Guro-gu, Seoul, Republic of Korea |
| Contact Person for Updating Information | |
| Name | Young sung Kim |
| Title | Dr |
| Telephone | +82-31-412-6716 |
| Affiliation | Koera University Guro Hospital |
| Address | 148, Gurodong-ro, Guro-gu, Seoul, Republic of Korea |
4. Status
| Study Site | Multi-center Number of center : 2 | |
|---|---|---|
| Overall Recruitment Status | Recruiting | |
| Date of First Enrollment | 2020-10-06 Actual | |
| Target Number of Participant | 400 | |
| Primary Completion Date | 2023-01-31 , Anticipated | |
| Study Completion Date | 2023-02-28 , Anticipated | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Korea University Ansan Hospital | |
| Recruitment Status | Recruiting | |
| Date of First Enrollment | 2020-10-06 , | |
| Recruitment Status by Participating Study Site 2 | ||
| Name of Study | Koera University Guro Hospital | |
| Recruitment Status | Recruiting | |
| Date of First Enrollment | 2020-12-22 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Korea Medical Device Development Fund |
| Organization Type | Others |
| Project ID | 2014X25 |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Korea University |
| Organization Type | University |
7. Study Summary
| Lay Summary | The CAI system based on the CAI algorithm that can measure the depth of anesthesia by directly measuring brain activity and the BIS are applied simultaneously to the patient undergoing anesthesia. 1) we compared the EEG findings from two devices, 2) secure large-scale data through research to conduct clinical performance evaluation of the CAI system, 3) overcome the problems of the existing anesthesia depth prediction model (BIS) 4) furthermore, we would like to conduct research for the occurrence of arousal under anesthesia during perioperative periods. |
|---|
8. Study Design
| Study Type | Observational Study |
|---|---|
| Observational Study Model | Case-only |
| Time Perspective | Prospective |
| Target Number of Participant | 400 |
| Cohort/Group Number | 1 |
|
Cohort/ Group 1 |
Cohort/Group Label A group for the patients undergoing general anesthesia or sedation. |
|
Cohort/Group Description This study is an observational study, and the group is not subdivided. When the results are analyzed, we confirmed each patient whether general anesthesia or sedation is provided. Details are described below. Primary endpoints: EEG findings from CAI and BIS; Secondary endpoints: Events during surgery (awakening, involuntary movements, BIS 60 or more increase during general anesthesia, BIS 80 or more increase during sedation) |
|
| Biospecimen Collection & Archiving |
Not collect nor Archive |
| Biospecimen Description |
9. Subject Eligibility
| Study Population Description | Patients over 20 years of age, I-III of ASA, who are planning to perform general anesthesia or sedation using inhalation anesthesia or total intravenous anesthesia. |
|---|---|
| Sampling Method | This study is an observational study, and consent is given to all patients who meet the conditions. |
| Condition(s)/Problem(s) |
Not Applicable-Anesthesia
All patients undergoing surgery requiring general anesthesia or sedation. |
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 20Year~No Limit |
|
|
Description Adult men and women over 20 years old |
|
| Exclusion Criteria |
BMI ≥ 35, a history of substance abuse or dependence, a history of allergy to anesthetic drugs, a history of dementia, patients with mental illness or taking psychiatric drugs, patients with speech impairment, a history of central nervous system or cerebrovascular disease. Patients who lack the ability to make decisions. |
| Healthy Volunteers | No |
10. Outcome Measure(s)
| Type of Primary Outcome | /Safety/Efficacy | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | Anesthetic depth using CAI or BIS |
|
| Timepoint | Perioperative periods |
|
| Secondary Outcome(s) 1 | ||
| Outcome | OASS (Observer's Assessment of Alertness/Sedation Scale) duing PACU |
|
| Timepoint | postoperative periods |
|
11. Study Results and Publication
| Result Registered | No |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | No |
|---|
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