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

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ClinicalTrials.gov Identifier: NCT04810481
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

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

Condition or disease Intervention/treatment Phase
Anesthesia Device: BIS Complete Monitoring System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: Investigator will be blinded to the BIS value in the Standard Practice Group
Primary Purpose: Health Services Research
Official Title: Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients Undergoing Sevoflurane Anesthesia (BTIGER)
Actual Study Start Date : July 2, 2021
Estimated Primary Completion Date : May 15, 2022
Estimated Study Completion Date : September 15, 2022

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 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.




Primary Outcome Measures :
  1. BIS performance [ Time Frame: duration of anesthesia administration ]
    To report the BIS range of values (0-100) with sevoflurane in pediatric patients ages 4 to 18 years. The BIS values from each group will be reported to show that the values are similar in the BIS group when compared to the Standard Practice Group. The BIS value correlates to the depth of anesthesia.


Secondary Outcome Measures :
  1. Recovery Assessments [ Time Frame: up to 4 hours following anesthesia administration ]

    Secondary endpoint(s):

    • Recovery assessments in patients receiving monitoring compared to standard anesthetic practice (instructions for collection contained in Study Procedures and Assessments):
    • Emergence, defined as the time when any of the following first occurred:
    • Eyes open spontaneously
    • Crying or phonating
    • Purposeful movements

  2. Modified Aldrete Score [ Time Frame: up to 4 hours following anesthesia administration ]
    The Modified Aldrete Score assesses the readiness of the subject to be discharged from the PACU with the higher the number correlating to the more ready a patient is to be discharged, the score range is 0-12.

  3. Anesthesia Airway Management [ Time Frame: up to 4 hours following anesthesia administration ]
    • Awake and Deep Extubation (endotracheal tube vs. laryngeal mask airway
    • Airway reflexes (e.g., coughing, choking, laryngospasm)

  4. Clinical Anesthesia Assessment [ Time Frame: up to 4 hours following anesthesia administration ]
    recorded as the incidence of movements, grimacing, eye opening, tearing, sweating, mydriasis and cardiovascular changes



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric Subjects (ASA PS 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04810481


Contacts
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Contact: Ami Stuart, PhD 801-793-4800 ami.stuart@medtronic.com
Contact: Stephanie Monza, BS 303-763-0813 stephanie.r.monza@medtronic.com

Locations
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United States, Colorado
Children's Hospital Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Rebecca Safon       Rebecca.Safon@childrenscolorado.org   
Principal Investigator: Richard Ing, MD         
United States, Illinois
Lurie Children's Hospital of Chicago Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Kathleen VantHof       KVantHof@luriechildrens.org   
Principal Investigator: Eric Cheon, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Katherine Sweeney, BSN    919-681-6221    katherine.sweeney@duke.edu   
Principal Investigator: Brad Taicher, DO         
United States, Pennsylvania
University of Pittsburgh Medical Center, Children's Hospital Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
University of Texas Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Marco Fierro, BS       Marco.Fierro@UTSouthwestern.edu   
Principal Investigator: Gijo Alex, MD         
Sponsors and Collaborators
Medtronic - MITG
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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT04810481    
Other Study ID Numbers: MDT20032BTIGER
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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