Characterization of Artifacts in the BIS™ EEG Signals in General Anesthesia Patients in Operating Room (RAMBAM)
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|ClinicalTrials.gov Identifier: NCT03553953|
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment|
|Anesthesia, General||Device: BIS device|
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 -
- Medical treatment (drug, dosage and time)
- Changes in hypnotic state (state, time)
- Any activity that may affect the EEG signals (i.e. electrical and mechanical artifacts from medical devices)
- Any activity that deviates from the clinical procedure
- 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|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|
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
- 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)
- 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™.
- 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)
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
|Contact: Raz Levin, Ph.Dfirstname.lastname@example.org|
|Rambam Health Care Campus||Recruiting|
|Haifa, Israel, 3109601|
|Contact: Aeyal Raz, MD; PhD email@example.com|
|Principal Investigator:||Aeyal Raz, MD; Ph.D||Rambam Health Care Campus|