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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Surgical Procedures, Operative

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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fNIR light emitting and sensing device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No