Surgical Procedures, Operative
Conditions
Keywords
No specific disease is being studied, few procedures are excluded., The focus of the study is to rule out the efficacy of the device, so the aim is to include as wide a variety of procedures as possible.
Brief summary
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.
Interventions
DEVICEfNIR light emitting and sensing device
Sponsors
Drexel University College of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed