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出境医 / 临床实验 / Association Between qEEG Measure and Post-Operative Cognitive Dysfunction (POCD) and Postoperative Delirium (POD)

Association Between qEEG Measure and Post-Operative Cognitive Dysfunction (POCD) and Postoperative Delirium (POD)

Study Description
Brief Summary:

Cognitive complications after major surgery are a common phenomenon. The incidence of Postoperative Cognitive Dysfunction (POCD), may vary from 5% to 25% in adult patients, depending on different risk factors. Age has been strongly associated with cognitive complications. POCD is a prolonged decline in cognitive function that appears after surgery as compared with preoperative functions. In order to classify evaluate POCD, it requires at least 2 measurements. A baseline, completed before surgery and a second measurement, post surgery.

In light of the high prevalence of POCD and the difficulties in its prediction, NeuroIndex has developed a quantitative EEG system and software that aim to produces risk predictor index (IS) for POCD. This study aims to evaluate the relationship between the software produced predictor index and the actual POCD events. The qEEG will be monitored during the surgery in addition to the routine clinical practice in operating rooms.

POCD will be evaluated using Montreal Cognitive Assessment test (MoCA) prior and post surgery.


Condition or disease Intervention/treatment
Cognitive Dysfunction Device: EEG monitoring

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Blind, Observational, Prospective, Multi -Center, One Arm, Study on the Association Between qEEG Measure and Post-Operative Cognitive Dysfunction (POCD) and Postoperative Delirium (POD)
Actual Study Start Date : September 23, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 1, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Patients over 65 years undergoing heart surgery
Patients over 65 years undergoing heart surgery under anesthesia, EEG monitored
 Device: EEG monitoring
EEG monitoring under general anesthesia
Outcome Measures
Primary Outcome Measures :
  1. The qEEG parameter IS correlation with POCD [ Time Frame: 1 week following surgery ]
    The qEEG parameter IS, which range between 0 and 1, where higher scores are more favorable than lower scores will be evaluated for its correlation with POCD that will be measured by Montreal Cognitive Assessment (MoCA)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will consist of male and female adults undergoing cardiac surgery under general anesthesia
Criteria

Inclusion Criteria:

  • Males and females between the ages of 65 or above.
  • Subjects with American Society of Anesthesiologists physical status I-III.
  • Subjects who are intended to undergo cardiac surgery (CABG or valve replacement) under general anesthesia.
  • Surgical procedures scheduled for over 30 minutes.
  • Lack of significant hearing disturbances.
  • Subjects with ability to read and understand the consent form.

Exclusion Criteria:

  • Significant visual impairment so that the pictures of the confusion assessment method could not be interpreted to accurately test to assess delirium.
  • Profound dementia or aphasia that interfered with the assessment of cognitive dysfunction (positive delirium in CAM-ICU).
  • Patients with a history of stroke.
  • Any documented major neurologic or psychiatric dysfunction.
  • Pregnant women.
  • Long term use of sedative-hypnotic drugs and antidepressant drug.
  • Subjects with scalp or skull abnormalities (s/p brain surgery, cranial implants).
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Ester Pri-Or, Nurse CRA 972-506629699 Ester@neuroindex.com
Contact: Tamar A Arens, Dr. 972543532120 Tamar@neuroindex.com

Locations
Layout table for location information
Israel
Carmel Medical Center Recruiting
Haifa, Israel, 3436212
Contact: Erez Sharoni, Dr    972-4-8250621    Esharoni@clalit.org.il   
Sponsors and Collaborators
Neuroindex Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Dror Leviner, Dr. Carmel Medical Center
Tracking Information
First Submitted Date June 4, 2019
First Posted Date June 6, 2019
Last Update Posted Date September 11, 2020
Actual Study Start Date September 23, 2019
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2019) 		The qEEG parameter IS correlation with POCD [ Time Frame: 1 week following surgery ]
The qEEG parameter IS, which range between 0 and 1, where higher scores are more favorable than lower scores will be evaluated for its correlation with POCD that will be measured by Montreal Cognitive Assessment (MoCA)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Association Between qEEG Measure and Post-Operative Cognitive Dysfunction (POCD) and Postoperative Delirium (POD)
Official Title A Blind, Observational, Prospective, Multi -Center, One Arm, Study on the Association Between qEEG Measure and Post-Operative Cognitive Dysfunction (POCD) and Postoperative Delirium (POD)
Brief Summary

Cognitive complications after major surgery are a common phenomenon. The incidence of Postoperative Cognitive Dysfunction (POCD), may vary from 5% to 25% in adult patients, depending on different risk factors. Age has been strongly associated with cognitive complications. POCD is a prolonged decline in cognitive function that appears after surgery as compared with preoperative functions. In order to classify evaluate POCD, it requires at least 2 measurements. A baseline, completed before surgery and a second measurement, post surgery.

In light of the high prevalence of POCD and the difficulties in its prediction, NeuroIndex has developed a quantitative EEG system and software that aim to produces risk predictor index (IS) for POCD. This study aims to evaluate the relationship between the software produced predictor index and the actual POCD events. The qEEG will be monitored during the surgery in addition to the routine clinical practice in operating rooms.

POCD will be evaluated using Montreal Cognitive Assessment test (MoCA) prior and post surgery.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population will consist of male and female adults undergoing cardiac surgery under general anesthesia
Condition Cognitive Dysfunction
Intervention Device: EEG monitoring
EEG monitoring under general anesthesia
Study Groups/Cohorts Patients over 65 years undergoing heart surgery
Patients over 65 years undergoing heart surgery under anesthesia, EEG monitored
Intervention: Device: EEG monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 4, 2019) 		50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2022
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Males and females between the ages of 65 or above.
  • Subjects with American Society of Anesthesiologists physical status I-III.
  • Subjects who are intended to undergo cardiac surgery (CABG or valve replacement) under general anesthesia.
  • Surgical procedures scheduled for over 30 minutes.
  • Lack of significant hearing disturbances.
  • Subjects with ability to read and understand the consent form.

Exclusion Criteria:

  • Significant visual impairment so that the pictures of the confusion assessment method could not be interpreted to accurately test to assess delirium.
  • Profound dementia or aphasia that interfered with the assessment of cognitive dysfunction (positive delirium in CAM-ICU).
  • Patients with a history of stroke.
  • Any documented major neurologic or psychiatric dysfunction.
  • Pregnant women.
  • Long term use of sedative-hypnotic drugs and antidepressant drug.
  • Subjects with scalp or skull abnormalities (s/p brain surgery, cranial implants).
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ester Pri-Or, Nurse CRA 972-506629699 Ester@neuroindex.com
Contact: Tamar A Arens, Dr. 972543532120 Tamar@neuroindex.com
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT03977350
Other Study ID Numbers CLD5
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Neuroindex Ltd.
Study Sponsor Neuroindex Ltd.
Collaborators Not Provided
Investigators
Principal Investigator: Dror Leviner, Dr. Carmel Medical Center
PRS Account Neuroindex Ltd.
Verification Date September 2020

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