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

NCT03553953 | Completed FDA Device

• 1 other identifier: MDT18003
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, General

Keywords

Anesthesia; Bispectral index (BIS™)

Outcome Measures

Primary Outcomes (1)

• Recording of data that potentially indicates artifacts

  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)

  24 hours or less

Secondary Outcomes (2)

• The effect of demographic and clinical parameters on EEG

  week or less

• Immediate post-operative data

  week or less

Study Arms (1)

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

Interventions

BIS device DEVICE

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

Patients with recording from BIS device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Study Officials

• Aeyal Raz, MD; Ph.D

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 12, 2018
• Study Start: August 15, 2018
• Primary Completion: August 11, 2020
• Study Completion: August 11, 2020
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)