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The purpose of this study is to investigate the relationship between BIS™ values including EEG profile and anesthetic agents in the pediatric population
This is a multi-center, prospective, observational, non-invasive, randomized controlled study to collect data to compare the performance of standard practice (SP) group with the BIS™ monitoring (BIS) group. Pediatric patients between the ages of 4 to 18 years undergoing routine sevoflurane general anesthesia with an expected surgical procedure duration of greater than 30 minutes will be recruited. If the surgery is less than 15 minutes, the data will continue to be collected, but will not be included in the data analysis and the subject will be replaced with an additional subject. General surgeries including abdominal, urological, orthopedic, or ophthalmological procedures with an American Society of Anesthesiologists physical status of I - III.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Practice | No Intervention | Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications. | |
| BIS Group | Active Comparator | Anesthesia will be titrated to achieve a BIS value of 45-60 during maintenance of anesthesia. Additional intervention will be provided only if the subject is in distress. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIS Complete Monitoring System | Device | The BIS™ complete monitoring system is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS™ complete system processes raw EEG signals to produce a single number, called the BIS™ index, which correlates with the patient's level of hypnosis. A sensor placed on the patient's head transmits EEG signals to the BISx™ unit. The BIS™ unit filters and digitizes the signal, analyzes it for the artifact, and processes it using digital signal processing techniques to derive processed EEG parameters to a single Bispectral Index (BIS™), and finally sends the processed data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal that the BIS™ algorithm can utilize to derive BIS Index. |
| Measure | Description | Time Frame |
|---|---|---|
| End-tidal Sevoflurane Concentration | Average end tidal (expired) sevoflurane (ETSevo) concentration during anesthesia maintenance in pediatric patients ages 4 to 18 years. The ETSevo values from each group will be reported to show that the values are different between the BIS group when compared to the Standard Practice Group. | duration of maintenance of anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Each Score on the Wong Baker Faces Scale | Wong Baker FACES Scale 0-5 with 0 = No Hurt and 5 = Hurt Most | up to 4 hours following anesthesia administration |
| Modified Aldrete Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States | ||
| Lurie Children's Hospital of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39754470 | Derived | Templeton TW, Alex G, Eloy JD, Stollings L, Ing RJ, Cheon EC, Belani K, Breskin I, Sebel PS, Taicher BM; BTiger Study Group. BIS Guided Titration of Sevoflurane in Pediatric Patients Undergoing Elective Surgery: A Randomized Controlled Trial. Paediatr Anaesth. 2025 Apr;35(4):277-286. doi: 10.1111/pan.15057. Epub 2025 Jan 4. |
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Subjects enrolled without randomization to group (n=39) include training subject (29), screen failure (n=4), physician decision (n=2), technical problem (n=1), and other (n=3)
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Practice | Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications. |
| FG001 | BIS Group | Anesthesia will be titrated to achieve a BIS value of 45-60 during maintenance of anesthesia. Additional intervention will be provided only if the subject is in distress. BIS Complete Monitoring System: The BIS™ complete monitoring system is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS™ complete system processes raw EEG signals to produce a single number, called the BIS™ index, which correlates with the patient's level of hypnosis. A sensor placed on the patient's head transmits EEG signals to the BIS™ unit. The BIS™ unit filters and digitizes the signal, analyzes it for the artifact, and processes it using digital signal processing techniques to derive processed EEG parameters to a single Bispectral Index (BIS™), and finally sends the processed data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal that the BIS™ algorithm can utilize to derive BIS Index. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Practice | Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications. |
| BG001 | BIS Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | End-tidal Sevoflurane Concentration | Average end tidal (expired) sevoflurane (ETSevo) concentration during anesthesia maintenance in pediatric patients ages 4 to 18 years. The ETSevo values from each group will be reported to show that the values are different between the BIS group when compared to the Standard Practice Group. | Data in table is shown for all ages (total) and broken down by age group | Posted | Mean | Standard Deviation | percent sevoflurane | duration of maintenance of anesthesia |
|
Adverse events were collected from enrollment through study exit, up to 24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Practice | Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith Holloman | Medtronic | 6126707136 | keith.holloman@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 23, 2023 | Feb 16, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2023 | Feb 16, 2023 | SAP_001.pdf |
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Investigator will be blinded to the BIS value in the Standard Practice Group
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The Modified Aldrete Score assesses the readiness of the subject to be discharged from the post anesthesia care unit (PACU) with the higher the number correlating to the more ready a patient is to be discharged, the score range is 0-12.
| up to 4 hours following anesthesia administration |
| Number of Participants With Reported Airway Reflexes | Airway reflexes (e.g., coughing, choking, laryngospasm) that are common in anesthesia and not considered adverse events | up to 4 hours following anesthesia administration |
| Clinical Anesthesia Assessment | recorded as the number of events including movement during procedure, eye opening, hypotension, hypertension, tachycardia, bradycardia, and low oxygen saturation (SpO2) that are common in anesthesia and not considered adverse events | up to 4 hours following anesthesia administration |
| Chicago |
| Illinois |
| 60611 |
| United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Rutgers University | Newark | New Jersey | 07103 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
| University of Pittsburgh Medical Center, Children's Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
Anesthesia will be titrated to achieve a BIS value of 45-60 during maintenance of anesthesia. Additional intervention will be provided only if the subject is in distress.
BIS Complete Monitoring System: The BIS™ complete monitoring system is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS™ complete system processes raw EEG signals to produce a single number, called the BIS™ index, which correlates with the patient's level of hypnosis. A sensor placed on the patient's head transmits EEG signals to the BISx™ unit. The BISx™ unit filters and digitizes the signal, analyzes it for the artifact, and processes it using digital signal processing techniques to derive processed EEG parameters to a single Bispectral Index (BIS™), and finally sends the processed data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal that the BIS™ algorithm can utilize to derive BIS Index.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Anesthesia will be titrated to achieve a BIS value of 45-60 during maintenance of anesthesia. Additional intervention will be provided only if the subject is in distress. BIS Complete Monitoring System: The BIS™ complete monitoring system is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS™ complete system processes raw EEG signals to produce a single number, called the BIS™ index, which correlates with the patient's level of hypnosis. A sensor placed on the patient's head transmits EEG signals to the BISx™ unit. The BISx™ unit filters and digitizes the signal, analyzes it for the artifact, and processes it using digital signal processing techniques to derive processed EEG parameters to a single Bispectral Index (BIS™), and finally sends the processed data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal that the BIS™ algorithm can utilize to derive BIS Index. |
|
|
| Secondary | Number of Participants With Each Score on the Wong Baker Faces Scale | Wong Baker FACES Scale 0-5 with 0 = No Hurt and 5 = Hurt Most | Posted | Count of Participants | Participants | up to 4 hours following anesthesia administration |
|
|
|
| Secondary | Modified Aldrete Score | The Modified Aldrete Score assesses the readiness of the subject to be discharged from the post anesthesia care unit (PACU) with the higher the number correlating to the more ready a patient is to be discharged, the score range is 0-12. | Lowest/worst timepoint reported | Posted | Mean | Standard Deviation | score on a scale | up to 4 hours following anesthesia administration |
|
|
|
| Secondary | Number of Participants With Reported Airway Reflexes | Airway reflexes (e.g., coughing, choking, laryngospasm) that are common in anesthesia and not considered adverse events | Posted | Number | participants | up to 4 hours following anesthesia administration |
|
|
|
| Secondary | Clinical Anesthesia Assessment | recorded as the number of events including movement during procedure, eye opening, hypotension, hypertension, tachycardia, bradycardia, and low oxygen saturation (SpO2) that are common in anesthesia and not considered adverse events | Posted | Number | participants | up to 4 hours following anesthesia administration |
|
|
|
| 0 |
| 76 |
| 1 |
| 76 |
| 4 |
| 76 |
| EG001 | BIS Group | Anesthesia will be titrated to achieve a BIS value of 45-60 during maintenance of anesthesia. Additional intervention will be provided only if the subject is in distress. BIS Complete Monitoring System: The BIS™ complete monitoring system is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS™ complete system processes raw EEG signals to produce a single number, called the BIS™ index, which correlates with the patient's level of hypnosis. A sensor placed on the patient's head transmits EEG signals to the BISx™ unit. The BISx™ unit filters and digitizes the signal, analyzes it for the artifact, and processes it using digital signal processing techniques to derive processed EEG parameters to a single Bispectral Index (BIS™), and finally sends the processed data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal that the BIS™ algorithm can utilize to derive BIS Index. | 0 | 56 | 0 | 56 | 3 | 56 |
| Device Issue | Product Issues | MedDRA (25.0) | Systematic Assessment |
|
| Procedural Complication | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
|
| Abdominal Abcess | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
|
| Endotracheal intubation complications | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
|
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| Wong Baker FACES Scale (Highest score during PACU stay) Hurt Little More |
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| Wong Baker FACES Scale (Highest score during PACU stay) Hurt even more |
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| Wong Baker FACES Scale (Highest score during PACU stay) Hurt whole lot |
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| Wong Baker FACES Scale (Highest score during PACU stay) Hurt worst |
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| Not Reported |
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| Laryngospasm |
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| Hypotension during procedure |
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| Hypertension during procedure |
|
| Tachycardia in recovery |
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| Bradycardia in recovery |
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| Hypotention in recovery |
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| Hypertension in recovery |
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| Low SPO2 in recovery |
|