Anesthesia, GeneralRAMBAMNCT03553953
Characterization of Artifacts in the BIS™ EEG Signals in General Anesthesia Patients in Operating Room
An observational study of Anesthesia, General, run by Medtronic - MITG at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- BIS device
- Type of treatment
- Medical device
- How many people
- 98 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Aug 2018to 11 Aug 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 -
- 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.
- Conditions
- Anesthesia, General
- Being tested
- BIS device
- Keywords
- Anesthesia, Bispectral index (BIS™)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS deviceDevice
Recording data from BIS device from patients who undergo elective surgery under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: BIS device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hours or less
Secondary outcomes (2)
The effect of demographic and clinical parameters on EEG
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™.
Measured: week or less
Immediate post-operative data
collect post-operative data in order to assess correlation between EEG data collected with the BIS™ and immediate post-operative delirium (POD)
Measured: week or less
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start15 Aug 2018
- Primary completion11 Aug 2020
- Study completion11 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aeyal Raz, MD; Ph.D, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553953
- Sponsor's protocol ID
- MDT18003
- Acronym
- RAMBAM
- Status last verified
- Sep 2020
- First submitted
- 31 May 2018
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Artifacts in the BIS™ EEG Signals in General Anesthesia Patients in Operating Room
- ClinicalTrials.gov ID
- NCT03553953
- Acronym / sponsor ID
- RAMBAM / MDT18003
- Conditions
- Anesthesia, General
- Keywords
- Anesthesia, Bispectral index (BIS™)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 11 Aug 2020 (actual)
- Study completion
- 11 Aug 2020 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 -
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with recording from BIS device | – | Device: BIS deviceOne 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIS deviceRecording data from BIS device from patients who undergo elective surgery under general anesthesia | Device | Patients with recording from BIS device |
Primary outcome
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)
2 secondary outcomes
The effect of demographic and clinical parameters on EEG
Time frame: week or less
Immediate post-operative data
Time frame: week or less
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aeyal Raz, MD; Ph.D principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, General, run by Medtronic - MITG at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recording of data that potentially indicates artifacts (time frame: 24 hours or less). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.