Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Characterization of Artifacts in the BIS™ EEG Signals in General Anesthesia Patients in Operating Room (RAMBAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553953
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Brief Summary:
This is an observational non-invasive study which aims to collect data from patients under general anesthesia in the operating room; this data will then be used for characterization and detection of artifacts that affect the EEG signal.

Condition or disease Intervention/treatment
Anesthesia, General Device: BIS device

Detailed Description:

This observational, non-invasive study will be performed in order to identify the effects of physiological and environmental artifacts on the EEG raw data collected by the BIS™. This study will include 100 screened subjects (not more than 60 valid cases) and will take place in the Department of Anesthesiology at Rambam Health Care Campus. During the study, raw data from the BIS™ will be recorded simultaneously with EMG, EOG and ECG in order to diagnose their effects on the EEG signals as recorded by the BIS™. The raw data will be considered as the main parameters of the study. Additionally, a study coordinator will stay in the operating room during the surgery and will indicate the following parameters -

  1. Medical treatment (drug, dosage and time)
  2. Changes in hypnotic state (state, time)
  3. Any activity that may affect the EEG signals (i.e. electrical and mechanical artifacts from medical devices)
  4. Any activity that deviates from the clinical procedure
  5. Any adverse events or unusual outcomes From the list above, parameters a, c and d will also be considered as main parameters and parameters and parameters d and e will be considered as safety parameters.

If applicable, BIS™ will be recorded after the surgery, at the PACU, for part of time the subject will be at the PACU or until the subject will be released from the department. The study coordinator/investigator will perform POD assessment at that time. The subject will be considered as valid case even if the data from the recovery room is missing.

Demographic details and medical history will be copied by the study coordinator from the subjects' medical records.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Characterization of Artifacts in the BIS™ EEG Signals in General Anesthesia Patients in Operating Room
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 1, 2020

Group/Cohort Intervention/treatment
Patients with recording from BIS device
One hundred screened adult patients and no more than 60 valid cases who undergo elective surgery under general anesthesia with recording from the BIS device at the same time and comply with the inclusions criteria
Device: BIS device
Recording data from BIS device from patients who undergo elective surgery under general anesthesia




Primary Outcome Measures :
  1. Recording of data that potentially indicates artifacts [ Time Frame: 24 hours or less ]

    The primary objective of the study is to measure and report:

    EMG, EOG and ECG data, each using the respective standard medical device for each parameter; EEG data using the BIS™ device; Environmental events occurring during the same time period (e.g. electrical artifacts)



Secondary Outcome Measures :
  1. The effect of demographic and clinical parameters on EEG [ Time Frame: week or less ]
    Generating a database of demographic and clinical data (e.g. level of consciousness, age, gender, BMI, anesthetic agents being used during the study, ASA level, etc.) in order to measure its effect on the EEG data collected with the BIS™.

  2. Immediate post-operative data [ Time Frame: week or less ]
    collect post-operative data in order to assess correlation between EEG data collected with the BIS™ and immediate post-operative delirium (POD)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will include maximum 100 screened adult patients and no more than 60 valid cases who will undergo elective surgery under general anesthesia and who will comply with the inclusions criteria
Criteria

Inclusion Criteria:

  • Men and Women
  • Age >18
  • Ability and willingness to participate in the study and sign informed consent form
  • Patients that will undergo elective surgery under general anesthesia.

Exclusion Criteria:

  • Pregnant women
  • Disability or unwillingness to undergo EEG/EMG/ECG measurement
  • Subjects with known or suspected sensitivity to adhesive bandage
  • Subjects who have sustained CVA or severe head trauma in the last 10 years.
  • Subjects with known or suspected electroencephalograph abnormality (e.g. epilepsy or scarring)
  • soldiers
  • prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553953


Contacts
Layout table for location contacts
Contact: Raz Levin, Ph.D 972-54-5449266 raz.levin@medtronic.com

Locations
Layout table for location information
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 3109601
Contact: Aeyal Raz, MD; PhD       ae_raz@rambam.health.gov.il   
Sponsors and Collaborators
Medtronic - MITG
Investigators
Layout table for investigator information
Principal Investigator: Aeyal Raz, MD; Ph.D Rambam Health Care Campus

Additional Information:

Layout table for additonal information
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT03553953     History of Changes
Other Study ID Numbers: MDT18003
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Medtronic - MITG:
Anesthesia
Bispectral index (BIS™)
Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs