Recall PhenomenonNCT03835156
Introducing a New EEG Based Index for Monitoring Recall Under Sedation
An observational study of Recall Phenomenon, run by Unity Health Toronto.
Trial summary
This is a single centre prospective observational study that will investigate a new EEG based index in recognizing recall of anesthesia in sedated patients. Awareness under general anesthesia is a dreadful complication. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Recall Phenomenon
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 31 Jan 2022
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All participants will receive detailed oral and printed information about the study and will sign a written informed consent form prior to study enrollment. Enrollment in the study is entirely voluntary, and declining to participate will in no way affect the quality or quantity of care provided to patients. Patients will have the right to withdraw from the study at any time.
Who may be able to join
- Research group:
- Patients old 18-80 years
- ASA I-III criteria
- Patients undergoing sedation for lithotripsy
- Control groups -
- Control general anesthesia group - Patients ASA I-III criteria, undergoing general anesthesia for general surgery
- Control awake group - Awake healthy volunteers,
Who cannot join
- Lack of informed consent, Age > 80 years, Age < 18 years pregnant women patients who do not comply with ASA I-III criteria.
Trial locations and contacts
No sites are listed yet.
About this study
This is a single centre prospective observational study that will investigate a new EEG based index in recognizing recall of anesthesia in sedated patients.
Awareness under general anesthesia is a dreadful complication. Various EEG-based technologies (such as BIS and others) were developed in order to identify this condition during anesthesia, using an EEG sticker on the forehead measuring the frontal EEG activity. However, these monitors might be inaccurate due to lack of sensitivity to various hypnotic agents as well as sensitivity to muscle activity, which might lead to report of deep anesthesia in the awake patient. Due to the very low prevalence of awareness under general anesthesia it is difficult to validate or invalidate the effectiveness of these monitors directly. Nevertheless, sedation often involves much greater prevalence of awareness, which permits to evaluate identification of recalled awareness with much humbler sample size.
Read more
The current available depth of anesthesia EEG based monitors are not effective in sedated patients since they are susceptible to muscle activity effect, which is present under sedation.
Based on the current literature in the field of electrophysiology the investigators have developed the anterior/ posterior (A/P) index (in the range of 0-100) for appreciating the anesthetic level. It is based on a comparison of anterior brain activity levels to posterior brain activity levels in response to anesthetic medication. The novelty of the index is stem from the fact that it is based on analyzing EEG data from only 4 electrodes covering the frontal and posterior brain activity. The investigators have shown in a proof of concept study performed in Rambam Hospital, Haifa, Israel that this index is not dependent on muscle activity thus is the only index that can identify recall in sedated patients.
- Conditions
- Recall Phenomenon
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification recall, using the new A/P index, in sedated patients
In this new following study, the investigators suggest to repeat the proof of concept study performed in Rambam Hospital, Israel (NIH trial registration: NCT02938325), with an FDA approved EEG system, with much better signal-to-noise ratio in order to demonstrate the ability to monitor awareness at the 30-seconds resolution scale.
The objective of this study will be to demonstrate that the A/P index, which is generated with an FDA approved EEG system, would relate to recall of awareness in sedation, with a better signal to noise ratio whereas a prefrontal based electrophysiological method (BIS) would not relate to recall.
Measured: 2 years
Secondary outcomes (1)
Identification recall, using a prefrontal based electrophysiological method (BIS) in sedated patients
Comparing the ability of BIS index to identify patients with recall under sedation, to the new A/P index
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Apr 2019 (estimated)
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recall PhenomenonStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Rigamonti, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835156
- Sponsor's protocol ID
- REB 18-308
- Status last verified
- Mar 2019
- First submitted
- 25 Jan 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducing a New EEG Based Index for Monitoring Recall Under Sedation
- ClinicalTrials.gov ID
- NCT03835156
- Acronym / sponsor ID
- REB 18-308
- Conditions
- Recall Phenomenon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 8 Feb 2019 (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 a single centre prospective observational study that will investigate a new EEG based index in recognizing recall of anesthesia in sedated patients.
Awareness under general anesthesia is a dreadful complication. Various EEG-based technologies (such as BIS and others) were developed in order to identify this condition during anesthesia, using an EEG sticker on the forehead measuring the frontal EEG activity. However, these monitors might be inaccurate due to lack of sensitivity to various hypnotic agents as well as sensitivity to muscle activity, which might lead to report of deep anesthesia in the awake patient. Due to the very low prevalence of awareness under general anesthesia it is difficult to validate or invalidate the effectiveness of these monitors directly. Nevertheless, sedation often involves much greater prevalence of awareness, which permits to evaluate identification of recalled awareness with much humbler sample size.
The current available depth of anesthesia EEG based monitors are not effective in sedated patients since they are susceptible to muscle activity effect, which is present under sedation.
Based on the current literature in the field of electrophysiology the investigators have developed the anterior/ posterior (A/P) index (in the range of 0-100) for appreciating the anesthetic level. It is based on a comparison of anterior brain activity levels to posterior brain activity levels in response to anesthetic medication. The novelty of the index is stem from the fact that it is based on analyzing EEG data from only 4 electrodes covering the frontal and posterior brain activity. The investigators have shown in a proof of concept study performed in Rambam Hospital, Haifa, Israel that this index is not dependent on muscle activity thus is the only index that can identify recall in sedated patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All participants will receive detailed oral and printed information about the study and will sign a written informed consent form prior to study enrollment. Enrollment in the study is entirely voluntary, and declining to participate will in no way affect the quality or quantity of care provided to patients. Patients will have the right to withdraw from the study at any time.
Key inclusion criteria (7 listed)
- Patients old 18-80 years
- ASA I-III criteria
- Patients undergoing sedation for lithotripsy
- Control groups -
- Control general anesthesia group - Patients ASA I-III criteria, undergoing general anesthesia for general surgery
Key exclusion criteria (1 listed)
- Lack of informed consent, Age > 80 years, Age < 18 years pregnant women patients who do not comply with ASA I-III criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification recall, using the new A/P index, in sedated patients
Time frame: 2 years
In this new following study, the investigators suggest to repeat the proof of concept study performed in Rambam Hospital, Israel (NIH trial registration: NCT02938325), with an FDA approved EEG system, with much better signal-to-noise ratio in order to demonstrate the ability to monitor awareness at the 30-seconds resolution scale. The objective of this study will be to demonstrate that the A/P index, which is generated with an FDA approved EEG system, would relate to recall of awareness in sedation, with a better signal to noise ratio whereas a prefrontal based electrophysiological method (BIS) would not relate to recall.
1 secondary outcome
Identification recall, using a prefrontal based electrophysiological method (BIS) in sedated patients
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Recall Phenomenon, run by Unity Health Toronto.
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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Rigamonti, MD (416-864-5825, RigamontiA@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification recall, using the new A/P index, in sedated patients (time frame: 2 years). 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 13 Mar 2019.