Records View
홈 아이콘 이미지
Search
Search
Search

A Clinical Trial to Collect the Biosignal Data for Pain Scale Algorithm in Surgical Patients

Status Approved

  • First Submitted Date

    2017/07/04

  • Registered Date

    2017/09/22

  • Last Updated Date

    2017/08/28

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number    		 KCT0002478
    Unique Protocol ID 2014-0347
    Public/Brief Title A Clinical Trial to Collect the Biosignal Data for Pain Scale Algorithm in Surgical Patients
    Scientific Title A Clinical Trial to Collect the Biosignal Data for Pain Scale Algorithm in Surgical Patients
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2014-0347
    Approval Date 2014-04-10
    Institutional Review Board Name Asan Medical Center Instituitional Review Board
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee No

  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Gyu-Jeong Noh
    Title M.D., Ph.D
    Telephone +82-2-3010-3855
    Affiliation Asan Medical Center
    Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea
    Contact Person for Public Queries
    Name Joohyun Lee
    Title Fellow
    Telephone +82-2-3010-0310
    Affiliation Asan Medical Center
    Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea
    Contact Person for Updating Information
    Name Joohyun Lee
    Title Fellow
    Telephone +82-2-3010-0310
    Affiliation Asan Medical Center
    Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea

  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2014-10-06 Actual
    Target Number of Participant 81
    Primary Completion Date 2014-10-21 , Actual
    Study Completion Date 2014-10-21 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Asan Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2014-10-06 ,

  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Trade, Industry & Energy
    Organization Type Government
    Project ID 10047988

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Asan Medical Center
    Organization Type Medical Institute

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    Biosignal data including electrocardiogram, photoplethymogram, pupil size was obtained before (no pain period) and after (pain period) surgical operation in patients undergoing elective surgery under general anesthesia. Also, raw photoplethysmogram and surgical pleth index were also recorded before and after intubation. The aim of this study is to establish new pain sclae algorithm using these biosignal data.

  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Prospective  
    Target Number of Participant 81
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    surgical patients undergoing elective surgery

    Cohort/Group Description

    In general, surgical patients undergoing elective surgery under general aneathesia did not have pain. However, they had severe pain after end of surgery. Hence, biosignal data were obtained before and after surgical operation. In addition, photoplethysmogram and surgical pleth index, analgesia nociception index were recored before and after intubation in patient received propofol and remifentanl using target-controlled infusion.
    Biospecimen
    Collection & Archiving    		 
    Not collect nor Archive
    Biospecimen Description 
    		
												
    
											    
										
    
									
									
								
							
    
						
    • 
						
  • 
							
    
								
    
									9. Subject Eligibility
								
    
								
							
    
							
    
								
    
									Subject Eligibility Information
									
										
											
    
												Study Population Description
												
    surgical patients undergoing elective surgery  
    		
											
    
											
    
												Sampling Method
												
    1. Patients undergoing elective surgery at E rosette in Asan Medical Center 
2. Patinet who had consented to this study  
    		
											
    
										
										
    
											Condition(s)/Problem(s)
											
												
												
												   Not Applicable-Etc 
												
												
											
										
    
										
    
											Rare Disease
											
												
													
													No
												
											
										
    
										
    
											
												Inclusion Criteria
											
											
												
    Gender
    
												Both
											    		
										
    
										
    
											
												
    Age
    
												20Year~64Year
											    		
										
    
										
    
											
												
    Description
    
												
    1. Patients undergoing elective surgery 
2. Age: <or = 20 and < or = 64
3. Patients under general anesthesia at E rosette in Asan Medical Center 
4. Patients who signed a written informed consent form 
    
											    		
										
    
										
    
											
												Exclusion Criteria
											
											
												
    	1. Patients who have desease associated with autonomic nervous system 
2. Rheumatoid arthritis, osteoarthritis, neurogenic pain, chronic pain 
3. Numerical rating scale for pain before surgery: more than or equal 1 
4. Blind 
5. Arrhythmia 
6. Patients who are considered by the investigator to be unsuitable to participate in the study for any other reason not mentioned in the inclusion and exclusion criteria 
    
											    		
										
    
										
    
											
												Healthy Volunteers
											
											
												
													
													No
												
											
										
    
									    
								
    
							
    
						
    • 
						
  • 
							
    
								
    
									10. Outcome Measure(s)
								
    
								
							
    
							
    
								
    
									Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
									
										
    
											
												
												Type of Primary Outcome
											
											 Not applicable
										
    
										
											
    
												
													Primary Outcome(s) 1
												
											
    
											
    
												Outcome
												
    surgical pleth index
    		
											
    
											
    
												Timepoint
												
    before and after operation
    		
											
    
										
										
											
    
												
													Secondary Outcome(s) 1
												
											
    
											
    
												Outcome
												
    analgesia nociception index
    		
											
    
											
    
												Timepoint
												
    before and after operation
    		
											
    
										
									    
								
    
							
    
						
    • 
						
  • 
							
    
								
    
									11. Study Results and Publication
								
    
								
							
    
							
    
								
    
									Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
									
										
    
											Result Registered
											
												
													
													
												
												
												
											
										
    
										
									    
								
    
							
    
						
    • 
						
  • 
							
    
								
    
									12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
								
    
								
							
    
							
    
								
    
									Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
									
										
    
											Sharing Statement
											
												
													
													No
													
												
											
										
    
										
									    
								
    
							
    
						
    • 
					

				

			

		

		

			
				
				Move list page
			
			
				
				Move to top
			
		

	







	

		

			
		

		

			
		

	





		






		

			

				
					화면 최상단으로 이동
				
				
TOP

			

			

				
BOTTOM

				
					화면 최하단으로 이동