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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00448877
Recruitment Status : Completed
First Posted : March 19, 2007
Last Update Posted : April 7, 2009
Information provided by:
Drexel University

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.

Condition or disease Intervention/treatment Phase
Surgical Procedures, Operative Device: fNIR light emitting and sensing device Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Deployment of Functional Optical Brain Monitor [fNIR] in Clinical Anesthesia
Study Start Date : December 2006
Actual Primary Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00448877

United States, Pennsylvania
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Drexel University College of Medicine
Study Chair: Jay Horrow, MD Drexel University College of Medicine

Responsible Party: Jerry Levitt, MD, Drexel University College of Medicine Identifier: NCT00448877     History of Changes
Other Study ID Numbers: 16618
First Posted: March 19, 2007    Key Record Dates
Last Update Posted: April 7, 2009
Last Verified: April 2008

Keywords provided by Drexel University:
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.