A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection
The purposes of this study are:
- To determine the sensitivity and specificity of the Near-Infrared Spectroscopy (NIRS) measurements for identifying intracranial hematomas due to trauma.
- To determine the reproducibility of the Near-Infrared Spectroscopy (NIRS) measurements with different operators and at different centers
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Diagnostic
|Official Title:||A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection|
- 1) Sensitivity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. 2) Specificity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
We will report Sensitivity and Specificity of NIRS device as compared to CT scanner to detect hematomas of more than 3.5 mL in volume and less than 2.5 cm from the surface of the brain.
Sensitivity is the ratio between true positives to all positive measurements. Specificity is the ratio between true negatives to all negative measurements.
- To Determine the Reproducibility of the Near-Infrared Spectroscopy (NIRS) Measurements With Different Operators and at Different Centers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Infrascanner measurment and CT scan
The standard head CT done to head trauma patients
The main Near-Infrared spectroscopy (NIRS) head measurement
The principle used in identifying intracranial hematomas with Near-infrared spectroscopy (NIRS) is that extravascular blood absorbs Near-infrared light more than intravascular blood since there is a greater (usually 10-fold greater) concentration of hemoglobin in the acute hematoma then in the brain tissue where blood is contained within vessels. Therefore, the absorbance of Near-infrared light is greater (and therefore the reflected light less) on the side of the brain containing a hematoma, than on the uninjured side.
The NIRS sensor is placed successively in the left and right frontal, temporal, parietal, and occipital areas of the head and the absorbance of light at selected wavelengths is recorded. The difference in optical density in the different areas is calculated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576147
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21231|
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|United States, Pennsylvania|
|The Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Claudia Robertson, MD||Professor Medical Director, The Center for Neurosurgical Intensive Care, Ben Taub Hospital, Houston, Texas|