Deployment of Functional Optical Brain Monitor [fNIR] in Clinical Anesthesia

Drexel University College of Medicine50 enrolled

Overview

The purpose of this study is to determine whether or not a new brain function monitor can distinguish between anesthetized and awake patients. The device implemented utilizes functional near-infrared (fNIR) technology to detect anesthesia depth as well as reaction to stimuli during surgical procedure. After obtaining consent the device is placed across the forehead of the patient. A baseline signal is obtained prior to induction. The fNIR signal is continuously recorded throughout the procedure. Key events as well as administration of drug are recorded in order to observe changes in the signal trend. Neither the device nor the light emitted is hazardous to the patient - no risks or discomforts are involved.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Surgical Procedures, Operative

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients who will have surgery * 18-80 years old * No restrictions on gender, race, or religion Exclusion Criteria: * Head and face surgery * Induced hypotension * Profound anemia * Scar/tattoo on forehead * Prior history of frontal lobe surgery * Hemoglobinopathies * Patients not undergoing general anesthesia * Surgeries in the prone position * Allergy to adhesive tape

Locations (1)

Hahnemann University Hospital

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

This is a proof of concept study, primary outcome measure includes observation and calculation of causal relationships of oxygenated and de-oxygenated hemoglobin during administration of anesthetic.

Data from ClinicalTrials.gov

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