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

This study has been completed.
Sponsor:
Information provided by:
Drexel University
ClinicalTrials.gov Identifier:
NCT00448877
First received: March 15, 2007
Last updated: April 6, 2009
Last verified: April 2008
History of Changes
  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: Open Label
Primary Purpose: Supportive Care
Official Title: Deployment of Functional Optical Brain Monitor [fNIR] in Clinical Anesthesia

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jerry Levitt, MD, Drexel University College of Medicine
ClinicalTrials.gov Identifier: NCT00448877     History of Changes
Other Study ID Numbers: 16618
Study First Received: March 15, 2007
Last Updated: April 6, 2009
Health Authority: United States: Institutional Review Board

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.

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2012