A Prospective, Multicenter, Single-Blind Study Assessing Indices of SNAP II Versus BIS VISTA on Surgical Patients Undergoing General Anesthesia.
BACKGROUND
Traditionally, anesthesiologists have relied on nonspecific subjective and objective physical signs to assess patients' comfort level and depth of anesthesia. Commercial development of electrical monitors, which use low- and high-frequency electroencephalogram (EEG) signals, have been developed to enhance the assessment of patients' level of consciousness. Multiple studies have shown that monitoring patients' consciousness levels can help in reducing drug consumption, anesthesia-related adverse events, and recovery time. This clinical study will provide information by simultaneously comparing the performance of the SNAP II (a single-channel EEG device) and the bispectral index (BIS) VISTA (a dual-channel EEG device) by assessing their efficacy in monitoring different anesthetic states in patients undergoing general anesthesia.


OBJECTIVE
The primary objective of this study is to establish the range of index values for the SNAP II corresponding to each anesthetic state (preinduction, loss of response, maintenance, first purposeful response, and extubation). The secondary objectives will assess the range of index values for BIS VISTA corresponding to each anesthetic state compared to published BIS VISTA range information, and estimate the area under the curve, sensitivity, and specificity for both devices.


METHODS
This is a multicenter, prospective, double-arm, parallel assignment, single-blind study involving patients undergoing elective surgery that requires general anesthesia. The study will include 40 patients and will be conducted at the following sites: The Ohio State University Medical Center (Columbus, OH); Northwestern University Prentice Women's Hospital (Chicago, IL); and University of Miami Jackson Memorial Hospital (Miami, FL). The study will assess the predictive value of SNAP II versus BIS VISTA indices at various anesthetic states in patients undergoing general anesthesia (preinduction, loss of response, maintenance, first purposeful response, and extubation). The SNAP II and BIS VISTA electrode arrays will be placed on the patient's forehead on opposite sides. The hemisphere location for both devices' electrodes will be equally alternated among the patient population. The index values for both devices will be recorded and correlated with the scorings received by performing the Modified Observer's Assessment of Alertness and Sedation and the American Society of Anesthesiologists Continuum of Depth of Sedation, at different stages of anesthesia.


RESULTS
Enrollment for this study has been completed and statistical data analyses are currently underway.


CONCLUSIONS
The results of this trial will provide information that will simultaneously compare the performance of SNAP II and BIS VISTA devices, with regards to monitoring different anesthesia states among patients.


BACKGROUND
Clinicaltrials.gov NCT00829803; https://clinicaltrials.gov/ct2/show/NCT00829803 (Archived by WebCite at http://www.webcitation.org/6nmyi8YKO).
Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH, United States.|Department of Neurological Surgery, The Ohio State University Wexner Medical Center, Columbus, OH, United States.
Sergio D
http://orcid.org/0000-0001-5641-5908
SD
Bergese
Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH, United States.
Alberto A
http://orcid.org/0000-0001-7897-8322
AA
Uribe
Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH, United States.
Erika G
http://orcid.org/0000-0002-6655-0203
EG
Puente
Department of Anesthesiology, Northwestern University Prentice Women's Hospital, Chicago, IL, United States.
R-Jay L
http://orcid.org/0000-0003-2998-7497
RL
Marcus
Stryker Corporation, Kalamazoo, MI, United States.
Randall J
http://orcid.org/0000-0002-4969-6622
RJ
Krohn
Stryker Corporation, Kalamazoo, MI, United States.
Steven
http://orcid.org/0000-0002-7295-3164
S
Docsa
Department of Anesthesiology, William Beaumont Hospital, Royal Oak, MI, United States.
Roy G
http://orcid.org/0000-0002-6910-9608
RG
Soto
Department of Anesthesiology, University of Miami/Jackson Memorial Hospital, Miami, FL, United States.
Keith A
http://orcid.org/0000-0003-4794-7261
KA
Candiotti
BIS VISTA; Bispectral index; EEG monitoring; SNAP II