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

Completed · Not applicable

Conditions studied: Surgical Procedures, Operative

In brief

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.

Key facts

Study ID

NCT00448877

Run by

Drexel University College of Medicine

People needed

50

Starts

2006-12-01

Last updated by the study team

2009-04-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients who will have surgery
• 18-80 years old
• No restrictions on gender, race, or religion

You may not qualify if…

• 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

Where it is running

• Hahnemann University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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