Trial Outcomes & Findings for Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients (NCT NCT04810481)

Last Updated: 2023-04-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

209 participants

Primary outcome timeframe

duration of maintenance of anesthesia

Results posted on

2023-04-18

Participant Flow

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)

Participant milestones

Participant milestones
Measure	Standard Practice Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications.	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.
Overall Study STARTED	86	84
Overall Study COMPLETED	76	56
Overall Study NOT COMPLETED	10	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Practice Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications.	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.
Overall Study Disqualified data sets	10	28

Baseline Characteristics

Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Practice n=76 Participants Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications.	BIS Group n=56 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.	Total n=132 Participants Total of all reporting groups
Age, Continuous	11.2 years STANDARD_DEVIATION 3.8 • n=5 Participants	11.0 years STANDARD_DEVIATION 3.9 • n=7 Participants	11.1 years STANDARD_DEVIATION 3.9 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	26 Participants n=7 Participants	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=5 Participants	38 Participants n=7 Participants	95 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants	33 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	76 participants n=5 Participants	56 participants n=7 Participants	132 participants n=5 Participants

PRIMARY outcome

Timeframe: duration of maintenance of anesthesia

Population: Data in table is shown for all ages (total) and broken down by age group

Outcome measures

Outcome measures
Measure	Standard Practice n=76 Participants Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications.	BIS Group n=56 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.
End-tidal Sevoflurane Concentration All Ages	2.1 percent sevoflurane Standard Deviation 0.5	1.8 percent sevoflurane Standard Deviation 0.4
End-tidal Sevoflurane Concentration Age 4-8 years	2.5 percent sevoflurane Standard Deviation 0.3	2.1 percent sevoflurane Standard Deviation 0.3
End-tidal Sevoflurane Concentration Age 9-12	2.2 percent sevoflurane Standard Deviation 0.6	1.7 percent sevoflurane Standard Deviation 0.5
End-tidal Sevoflurane Concentration Age 13-18	1.9 percent sevoflurane Standard Deviation 0.5	1.5 percent sevoflurane Standard Deviation 0.3

SECONDARY outcome

Timeframe: up to 4 hours following anesthesia administration

Wong Baker FACES Scale 0-5 with 0 = No Hurt and 5 = Hurt Most

Outcome measures

Outcome measures
Measure	Standard Practice n=76 Participants Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications.	BIS Group n=56 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.
Number of Participants With Each Score on the Wong Baker Faces Scale Wong Baker FACES Scale (Highest score during PACU stay) No Hurt	19 Participants	5 Participants
Number of Participants With Each Score on the Wong Baker Faces Scale Wong Baker FACES Scale (Highest score during PACU stay) Hurt Little Bit	14 Participants	18 Participants
Number of Participants With Each Score on the Wong Baker Faces Scale Wong Baker FACES Scale (Highest score during PACU stay) Hurt Little More	19 Participants	17 Participants
Number of Participants With Each Score on the Wong Baker Faces Scale Wong Baker FACES Scale (Highest score during PACU stay) Hurt even more	11 Participants	4 Participants
Number of Participants With Each Score on the Wong Baker Faces Scale Wong Baker FACES Scale (Highest score during PACU stay) Hurt whole lot	4 Participants	8 Participants
Number of Participants With Each Score on the Wong Baker Faces Scale Wong Baker FACES Scale (Highest score during PACU stay) Hurt worst	4 Participants	3 Participants
Number of Participants With Each Score on the Wong Baker Faces Scale Not Reported	5 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 4 hours following anesthesia administration

Population: Lowest/worst timepoint reported

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.

Outcome measures

Outcome measures
Measure	Standard Practice n=76 Participants Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications.	BIS Group n=56 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.
Modified Aldrete Score	7.3 score on a scale Standard Deviation 2.1	8.1 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: up to 4 hours following anesthesia administration

Airway reflexes (e.g., coughing, choking, laryngospasm) that are common in anesthesia and not considered adverse events

Outcome measures

Outcome measures
Measure	Standard Practice n=76 Participants Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications.	BIS Group n=56 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.
Number of Participants With Reported Airway Reflexes Coughing	13 participants	4 participants
Number of Participants With Reported Airway Reflexes Choking	0 participants	0 participants
Number of Participants With Reported Airway Reflexes Laryngospasm	0 participants	0 participants

SECONDARY outcome

Timeframe: up to 4 hours following anesthesia administration

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

Outcome measures

Outcome measures
Measure	Standard Practice n=76 Participants Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications.	BIS Group n=56 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.
Clinical Anesthesia Assessment Movement during procedure	5 participants	5 participants
Clinical Anesthesia Assessment Eye opening during procedure	3 participants	3 participants
Clinical Anesthesia Assessment Hypotension during procedure	1 participants	0 participants
Clinical Anesthesia Assessment Hypertension during procedure	1 participants	0 participants
Clinical Anesthesia Assessment Tachycardia in recovery	31 participants	33 participants
Clinical Anesthesia Assessment Bradycardia in recovery	18 participants	4 participants
Clinical Anesthesia Assessment Hypotention in recovery	39 participants	19 participants
Clinical Anesthesia Assessment Hypertension in recovery	24 participants	18 participants
Clinical Anesthesia Assessment Low SPO2 in recovery	0 participants	1 participants

Adverse Events

Standard Practice

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

BIS Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard Practice n=76 participants at risk Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications.	BIS Group n=56 participants at risk 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.
General disorders Pain	1.3% 1/76 • Number of events 1 • Adverse events were collected from enrollment through study exit, up to 24 hours	0.00% 0/56 • Adverse events were collected from enrollment through study exit, up to 24 hours

Other adverse events

Other adverse events
Measure	Standard Practice n=76 participants at risk Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications.	BIS Group n=56 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/76 • Adverse events were collected from enrollment through study exit, up to 24 hours	1.8% 1/56 • Number of events 1 • Adverse events were collected from enrollment through study exit, up to 24 hours
Product Issues Device Issue	0.00% 0/76 • Adverse events were collected from enrollment through study exit, up to 24 hours	1.8% 1/56 • Number of events 1 • Adverse events were collected from enrollment through study exit, up to 24 hours
Injury, poisoning and procedural complications Procedural Complication	0.00% 0/76 • Adverse events were collected from enrollment through study exit, up to 24 hours	1.8% 1/56 • Number of events 1 • Adverse events were collected from enrollment through study exit, up to 24 hours
Infections and infestations Abdominal Abcess	1.3% 1/76 • Number of events 1 • Adverse events were collected from enrollment through study exit, up to 24 hours	0.00% 0/56 • Adverse events were collected from enrollment through study exit, up to 24 hours
Injury, poisoning and procedural complications Endotracheal intubation complications	1.3% 1/76 • Number of events 1 • Adverse events were collected from enrollment through study exit, up to 24 hours	0.00% 0/56 • Adverse events were collected from enrollment through study exit, up to 24 hours
Psychiatric disorders Delirium	1.3% 1/76 • Number of events 1 • Adverse events were collected from enrollment through study exit, up to 24 hours	0.00% 0/56 • Adverse events were collected from enrollment through study exit, up to 24 hours
Vascular disorders Hypotension	1.3% 1/76 • Number of events 1 • Adverse events were collected from enrollment through study exit, up to 24 hours	0.00% 0/56 • Adverse events were collected from enrollment through study exit, up to 24 hours

Additional Information

Keith Holloman

Medtronic

Phone: 6126707136

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place