Depth of Anesthesia MonitoringNCT03947060
The Alternative Position for the SedLine® Sensor
An observational study of Depth of Anesthesia Monitoring, run by Cleveland Clinic Abu Dhabi at 1 site in United Arab Emirates.
Trial summary
SedLine® Brain Function Monitoring provides real-time insight into a patient's depth of anesthesia with bilateral data acquisition and processing of electroencephalogram (EEG) signals. Four active EEG leads collect data from the frontal lobe with a sensor position on the patient's forehead. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depth of Anesthesia Monitoring
- How many people
- 40 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Dec 2019to 1 Apr 2020
- 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: For each of the two modes of measurement, 1800 data points per subject (1 reading every 2 seconds for 1 hour) per hour will be collected. Assuming a maximum interclass correlation coefficient of .90, a sample size of 40 patients will be required to test the null hypotheses that the two modes of measurement share 95% of their variance via the construction of a 95% confidence interval that ranges no more than +/-5%. Data from the 2 placements will be compared and analyzed using a Bland-Altman analysis, a Scatter plot analysis, and a matched-pair analysis.
Who may be able to join
- Patients older than 18 years of age, both genders.
- Patients undergoing simple or complex surgery.
- American Society of Anesthesiologists Classification (ASA) score I to III.
Who cannot join
- American Society of Anesthesiologists Classification (ASA) score IV and V.
- Emergency cases
- Cognitive/Mentally impaired or unable to provide consent
- Previous neurological problems affecting EEG
- Dementia
- Use of sedative or drugs that can alter EEG readings
- Patients under head and neck surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BI-SENSES: Validation of Nasal Versus Frontal Placement of the SedLine® Sensor Through Processed Electroencephalography in Adult Patients Undergoing General Anesthesia
SedLine® Brain Function Monitoring provides real-time insight into a patient's depth of anesthesia with bilateral data acquisition and processing of electroencephalogram (EEG) signals. Four active EEG leads collect data from the frontal lobe with a sensor position on the patient's forehead.
Whenever a frontal approach for neurosurgical procedures is required or the frontal placement of the EEG is not indicated, it would not be possible to place the SedLine® .
Numerous studies have analyzed the change of position and the application of alternative positions for other devices used in assessing the depth of anesthesia. Albeit, yet to date, there is no study that analyzed the application of alternative positions for the SedLine® sensor.
Read the detailed description
The purpose of study is to compare the standard forehead placement versus a nasal placement of SedLine® sensor for neuromonitoring.
The hypothesis is that placing the central sensors in the montage approximately 2 cm below the standard recommended placement, across the nasal bridge and then running under the eyes to the normal temporal leads placement would put the entire montage out of the operative field and would still have corresponding values and EEG signals.
The primary outcome measure is to monitor and compare processed electroencephalograph (EEG) values (PSi- Patient State Index, SEFL- Spectral Edge Frequency Left, SEFR- Spectral Edge Frequency Right, SR-Suppression Ratio, EMG-Electromyography, ARTF-Artifact) and EEG waveforms, on both sensors (standard-Forehead and alternative-Nasal)
Other parameters that will be measure are patient demographics (age, sex, surgery, ASA status, weight, height, BMI).
- Conditions
- Depth of Anesthesia Monitoring
- Keywords
- Depth of anesthesia, SedLine® sensor, Alternative position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nasal & Frontal sensor position | One group of participants with two modes of measurement. First mode is standard frontal placement of the SedLine® sensor. Second mode is alternative nasal placement of the SedLine® sensor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of nasal SedLine® EEG sensor position for monitoring the depth of anesthesia using processed electroencephalograph values
Determine whether it is possible to apply an alternative SedLine® EEG sensor position in a situation where a standard-forehead position is not possible.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 Dec 2019
- Primary completion29 Feb 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depth of Anesthesia MonitoringStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Clinic Abu Dhabi
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Corporation
- Responsible party
- Principal investigator, Boris Tufegdzic, Cleveland Clinic Abu Dhabi
- Investigators
- Boris Tufegdzic, MD, Principal investigator, Cleveland Clinic Abu Dhabi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947060
- Sponsor's protocol ID
- A-2019-028
- Status last verified
- Jul 2020
- First submitted
- 7 May 2019
- Last updated
- 15 Jul 2020
- 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 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BI-SENSES: Validation of Nasal Versus Frontal Placement of the SedLine® Sensor Through Processed Electroencephalography in Adult Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT03947060
- Acronym / sponsor ID
- A-2019-028
- Conditions
- Depth of Anesthesia Monitoring
- Keywords
- Depth of anesthesia, SedLine® sensor, Alternative position
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cleveland Clinic Abu DhabiUniversity, hospital or other
- Collaborators
- Masimo Corporation
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 13 May 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.
SedLine® Brain Function Monitoring provides real-time insight into a patient's depth of anesthesia with bilateral data acquisition and processing of electroencephalogram (EEG) signals. Four active EEG leads collect data from the frontal lobe with a sensor position on the patient's forehead.
Whenever a frontal approach for neurosurgical procedures is required or the frontal placement of the EEG is not indicated, it would not be possible to place the SedLine® .
Numerous studies have analyzed the change of position and the application of alternative positions for other devices used in assessing the depth of anesthesia. Albeit, yet to date, there is no study that analyzed the application of alternative positions for the SedLine® sensor.
Detailed description
The purpose of study is to compare the standard forehead placement versus a nasal placement of SedLine® sensor for neuromonitoring.
The hypothesis is that placing the central sensors in the montage approximately 2 cm below the standard recommended placement, across the nasal bridge and then running under the eyes to the normal temporal leads placement would put the entire montage out of the operative field and would still have corresponding values and EEG signals.
The primary outcome measure is to monitor and compare processed electroencephalograph (EEG) values (PSi- Patient State Index, SEFL- Spectral Edge Frequency Left, SEFR- Spectral Edge Frequency Right, SR-Suppression Ratio, EMG-Electromyography, ARTF-Artifact) and EEG waveforms, on both sensors (standard-Forehead and alternative-Nasal)
Other parameters that will be measure are patient demographics (age, sex, surgery, ASA status, weight, height, BMI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal & Frontal sensor position | – | –One group of participants with two modes of measurement. First mode is standard frontal placement of the SedLine® sensor. Second mode is alternative nasal placement of the SedLine® sensor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For each of the two modes of measurement, 1800 data points per subject (1 reading every 2 seconds for 1 hour) per hour will be collected. Assuming a maximum interclass correlation coefficient of .90, a sample size of 40 patients will be required to test the null hypotheses that the two modes of measurement share 95% of their variance via the construction of a 95% confidence interval that ranges no more than +/-5%. Data from the 2 placements will be compared and analyzed using a Bland-Altman analysis, a Scatter plot analysis, and a matched-pair analysis.
Key inclusion criteria (3 listed)
- Patients older than 18 years of age, both genders.
- Patients undergoing simple or complex surgery.
- American Society of Anesthesiologists Classification (ASA) score I to III.
Key exclusion criteria (7 listed)
- American Society of Anesthesiologists Classification (ASA) score IV and V.
- Emergency cases
- Cognitive/Mentally impaired or unable to provide consent
- Previous neurological problems affecting EEG
- Dementia
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
Validation of nasal SedLine® EEG sensor position for monitoring the depth of anesthesia using processed electroencephalograph values
Time frame: One year
Determine whether it is possible to apply an alternative SedLine® EEG sensor position in a situation where a standard-forehead position is not possible.
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 15 Jul 2020.
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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.
Boris Tufegdzic, MD principal investigator
Cleveland Clinic Abu Dhabi
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 Depth of Anesthesia Monitoring, run by Cleveland Clinic Abu Dhabi at 1 site in United Arab Emirates.
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 3 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 15 Jul 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 United Arab Emirates. 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?
Validation of nasal SedLine® EEG sensor position for monitoring the depth of anesthesia using processed electroencephalograph values (time frame: One year). 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 15 Jul 2020.