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Completed

NCT Number: NCT03553953

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

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.

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Key information

Conditions

Anesthesia, General

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rambam Health Care Campus

Haifa, 3109601, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIS device

Device

Recording data from BIS device from patients who undergo elective surgery under general anesthesia

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Acronym: RAMBAM

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 12, 2018
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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