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

Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients Undergoing Sevoflurane Anesthesia (BTIGER)

The purpose of this study is to investigate the relationship between BIS™ values including EEG profile and anesthetic agents in the pediatric population

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Device: BIS Complete Monitoring System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Lurie Children's Hospital of Chicago
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Rutgers University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • University of Pittsburgh Medical Center, Children's Hospital
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pediatric Subjects (ASA physical status I or II or III) aged: 4 years to 18 years scheduled for procedures with sedation where the process of assessment will not interfere with the procedure, progress, or patient care

Exclusion Criteria:

• Has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes, or other medical sensors
• Known neurological disorder (e.g., epilepsy, the presence of a brain tumor, a history of brain surgery, hydrocephalic disorders, depression needing treatment with anti-depressive drugs, a history of brain trauma, hemiplegia, demyelinating disorders, cerebral palsy, congenital anomalies of the brain or spinal cord, or other known neurologic disorders)
• Severe developmental delay per assessment of investigator or report of parent/guardian
• Airway abnormalities
• Pregnancy; subjects of childbearing potential will have a urine screen for pregnancy before surgery
• If the process of assessment will interfere with the procedure or the progress of the procedure
• Taking psychoactive medications
• Taking any medications that may have an impact on the Central Nervous System (CNS)
• Planned use of any regional anesthesia; a local field block is not included in this exclusion and can be used at the discretion of the anesthesia provider

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Practice; Anesthesia will be provided at the discretion of the anesthesiologist following cardiovascular variables in accordance with usual clinical indications.
Active Comparator: 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.	Device: 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Medtronic - MITG

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Actual): October 12, 2022
• Study Completion (Actual): October 12, 2022

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MDT20032BTIGER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes