Deployment of Functional Optical Brain Monitor [fNIR] in Clinical Anesthesia
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|ClinicalTrials.gov Identifier: NCT00448877|
Recruitment Status : Completed
First Posted : March 19, 2007
Last Update Posted : April 7, 2009
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 or disease||Intervention/treatment||Phase|
|Surgical Procedures, Operative||Device: fNIR light emitting and sensing device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|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|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||July 2007|
- 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.
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
|United States, Pennsylvania|
|Hahnemann University Hospital|
|Philadelphia, Pennsylvania, United States, 19102|
|Study Chair:||Jay Horrow, MD||Drexel University College of Medicine|