Deployment of Functional Optical Brain Monitor [fNIR] in Clinical Anesthesia
- Conditions
- Surgical Procedures, Operative
- Registration Number
- NCT00448877
- Lead Sponsor
- Drexel University College of Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- All patients who will have surgery
- 18-80 years old
- No restrictions on gender, race, or religion
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States