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.

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Key information

Conditions

Surgical Procedures, Operative

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fNIR light emitting and sensing device

Device

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Drexel University College of Medicine

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2007
First posted: Mar 19, 2007
Registry last updated: Apr 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed