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

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 Overview

• Status: Completed
• Conditions: Surgical Procedures, Operative
• Intervention / Treatment: Device: fNIR light emitting and sensing device

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Hahnemann University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Drexel University College of Medicine
• Investigators: Study Chair: Jay Horrow, MD, Drexel University College of Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: March 15, 2007
• First Submitted That Met QC Criteria: March 16, 2007
• First Posted (Estimate): March 19, 2007

Study Record Updates

• Last Update Posted (Estimate): April 7, 2009
• Last Update Submitted That Met QC Criteria: April 6, 2009
• Last Verified: April 1, 2008

More Information

Terms related to this study

• 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.
• Other Study ID Numbers: 16618