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

Surgical Procedures, Operative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448877
• Other study ID #: 16618
• Status: Completed
• Phase: N/A
• First received: March 15, 2007
• Last updated: April 6, 2009
• Start date: December 2006

Study information

• Verified date: April 2008
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Surgical Procedures, Operative

Intervention

Device:
• fNIR light emitting and sensing device

Locations

Country	Name	City	State
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.