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Preliminary Studies with Infrascanner prototype

A dual wavelength reflectance spectrometer (Runman) was used in the pilot studies. This monitor is small (6.5 inches X 4.5 inches X 2 inches), battery-operated, and can be easily transported into the emergency room or intensive care unit. The probe consists of 2 small incandescent bulbs placed 4.5 cm on either side of a 760 and 850 nm photodetectors. The 4.5 cm separation of light source and detector allows measurement of NIR absorbance in a volume of tissue approximately 2 cm wide by 2 to 3 cm deep. Leakage of the light is minimized by the presence of rubber dams between the light emitter and detectors, and around the circumference of the probe. The procedure for a NIRS examination using the RUNMAN equipment takes less than ten minutes.

In the pilot study, a NIRS examination was obtained in the ER at the time of the admission CT scan. The maximal ΔOD among the various regions examined was recorded for each patient and was correlated with the admission CT scan.

Using the RUNMAN NIRS, serial measurements of ΔOD have been obtained in 305 head-injured patients under previous Baylor College of Medicine IRB protocols (#H-1492 and #H-949). As shown in Fig. 1, ΔOD on admission to the hospital was significantly elevated (>0.05) in all but 4 (2%) patients with intracranial hematomas. ΔOD was normal (0.00-0.05) in patients with diffuse brain injury (DBI) (Fig. 1-bottom). With extracerebral hematomas, where the blood was in the configuration of a layer, the thickness of the hematoma measured on the initial CT scan was directly related to the ΔOD (Fig. 2).

Fig. 1. Distribution of maximal ∆OD in 302 patients with various types of intracranial injuries: EDH – Epidural Hematoma, SDH – Subdural Hematoma, ICH – Intracerebral Hematoma, DBI – Diffuse brain injury


Fig. 2. Relationship between maximal ∆OD and the thickness of the hematoma on CT scan

A single NIRS examination therefore reliably identified patients with an intracranial hematoma (98% had a ΔOD > 0.05), and gave a suggestion of whether the hematoma was intracerebral (most had a ΔOD <0.6) or extracerebral (most had a ΔOD >0.6). This type of information would be useful in the initial assessment of a head-injured patient (1) in the field to triage patients likely to require surgery directly to a hospital having a neurosurgeon, (2) in emergency rooms where CT scanning is not immediately available, and (3) as a less expensive screening exam than CT scan for patients with mild head injury (who have an incidence of hematomas of only 1%). Serial NIRS examinations might be used in the ICU setting to detect development of delayed or postoperative intracranial hematomas.

In a pilot study of reproducibility, 10 patients were examined independently by two different operators. The ΔOD was calculated by the formula ΔOD = log (lright / Ileft) so that a negative ΔOD indicated a greater absorbance on the right, and a positive ΔOD indicted a greater absorbance on the left. The results show fairly good reproducibility when there is no intracranial lesion. When an intracranial lesion was present, the variability of ΔOD values was greater between the two operators. However, with both operators the ΔOD was significantly greater in the patients with a focal lesion than with no focal lesion, and the side of greatest absorbance of the NIR light indicated the side of the focal lesion.

       

The Infrascanner is not available for sale in the United States and is limited by federal law to investigational use.

Phone: 215.387.6784  Fax: 215.386.2327  Email: info@infrascanner.com
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