We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00448877
First Posted: March 19, 2007
Last Update Posted: April 7, 2009
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.
Information provided by:
Drexel University
  Purpose

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 Intervention
Surgical Procedures, Operative Device: fNIR light emitting and sensing device

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • 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.

Enrollment: 50
Study Start Date: December 2006
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00448877


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

Responsible Party: Jerry Levitt, MD, Drexel University College of Medicine
ClinicalTrials.gov Identifier: NCT00448877     History of Changes
Other Study ID Numbers: 16618
First Submitted: March 15, 2007
First Posted: March 19, 2007
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.