Bispectral Index: A Comparison of Bifrontal Montage Agreement

NCT04062240 | Completed Results FDA Device

• 1 other identifier: 19-000568
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers are trying to compare the results of two sensors when recorded simultaneously on opposite sides of the forehead.

Conditions

Surgery; Bispectral Index

Keywords

BIS; Bispectral Index; Paralysis

Outcome Measures

Primary Outcomes (1)

• BIS Montage

  Degree of variability between the values produced by the BIS sensors in a bifrontal montage when monitored simultaneously by use of a Bland-Altmann plot. The average value of each timed pair was plotted against the difference between the pairs. The BIS monitor outputs data on a scale of 0-100 in arbitrary units; 0 = an isoelectric state on EEG, 100 = fully awake patient. BIS values of 40-60 are thought to reduce the chance of patient recall during general anesthesia. For the purpose of this study, a smaller confidence interval is better as it indicates a higher level of agreement between the two BIS sensors.

  10 minutes where both sensors are recording concurrently

Secondary Outcomes (1)

• Ketamine

  10 minutes where both sensors are recording concurrently

Study Arms (1)

Additional BIS sensor

Many providers caring for cardiovascular surgical patients utilizes BIS monitoring to gauge depth of anesthesia. The current practice involves placement of the BIS sensor on the patient's forehead per the manufacturer's recommendation on arrival to the operating room. The intervention in this study will add an additional BIS sensor to the patient's forehead. After syncing the two monitors for time, and ensuring appropriate skin contact and signal quality of both sensors, BIS monitoring will commence. BIS readings will be available every 12 seconds during the duration of the study, yielding up to 240 points of comparison per enrolled patient.

Device: BIS sensor

Interventions

BIS sensor DEVICE

BIS sensors will be labeled L and R. The degree of variability between the concurrent use of the sensors will be assessed .

Additional BIS sensor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients undergoing elective cardiac surgery, for whom BIS monitoring will be used.

You may qualify if:

• \. Adult patient having elective cardiac surgery

You may not qualify if:

• Patient refusal.
• Pediatric patients.
• Emergency procedure.
• Patients with known or suspected carotid or cerebrovascular disease.
• Patients with prior stroke.
• Skin condition or anatomy preventing proper sensor placement.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

• Messner M, Beese U, Romstock J, Dinkel M, Tschaikowsky K. The bispectral index declines during neuromuscular block in fully awake persons. Anesth Analg. 2003 Aug;97(2):488-491. doi: 10.1213/01.ANE.0000072741.78244.C0.

  PMID: 12873942 RESULT

• Schuller PJ, Newell S, Strickland PA, Barry JJ. Response of bispectral index to neuromuscular block in awake volunteers. Br J Anaesth. 2015 Jul;115 Suppl 1:i95-i103. doi: 10.1093/bja/aev072.

  PMID: 26174308 RESULT

• Vivien B, Di Maria S, Ouattara A, Langeron O, Coriat P, Riou B. Overestimation of Bispectral Index in sedated intensive care unit patients revealed by administration of muscle relaxant. Anesthesiology. 2003 Jul;99(1):9-17. doi: 10.1097/00000542-200307000-00006.

  PMID: 12826836 RESULT

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Paralysis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Matthew Ritter
• Organization: Mayo Clinic

Ritter.Matthew@mayo.edu

507-255-5123

Study Officials

• Matthew Ritter, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 20, 2019
• Study Start: November 27, 2019
• Primary Completion: June 1, 2021
• Study Completion: October 1, 2021
• Last Updated: February 21, 2023
• Results First Posted: February 21, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)