Clinical Testing

EMI has prototype units being tested in two metro hospital’s emergency departments. Patients presenting with a chest trauma are evaluated utilizing the PneumoScan prior to any intervention by the clinical staff. The patient is then evaluated according to the standard treatment protocol of the hospital (chest x-ray or CT scan) The results of the PneumoScan are compared to the results of the chest x-ray or the CT scan.

Clinical Study Patient Results Summary

Table 1 highlights the clinical results to date.

91%

85%

Combined Results – Laptop Device

The overall accuracy of our non-invasive pneumothorax detector in identifying a patient with a pneumothorax was 91%, with 4 false positives and 1 false negative. Of the 4 false positives, the likely cause of 3 of them was determined by radiographic results. One patient had bibasilar atelectasis (a collection of fluid or mucous in the air sacs). Another patient had a chest tube in place on the left side and a hemothorax (a collection of blood in the pleural space) at the apex of the left side. A third patient had displaced acute left rib fractures and a slight deformity in the right rib cage. The fourth false positive was on a control patient (“known none”) for which there were no radiographic results available; therefore a determination of cause for the false reading could not be evaluated.

The one false negative indicated by our device was not initially detected by the chest x-ray, and was only observed when a follow-on contrast CT scan was performed. The physician determined that this pneumothorax was extremely small and did not warrant clinical treatment.

The overall accuracy for determination of the location of the pneumothorax is 85%. Excluding the false negatives discussed above, all of the remaining false side indications were for cases in which the patient had a large pneumothorax on one side only, whereas our device reported a positive on both sides. This is due to the fact that the radar antenna used during the initial studies had a fairly wide beam spread, resulting in crossover of the signal from one side to the other (in other words, a measurement taken on the right side received echoes back from a pneumothorax on the left side, or vice versa). This has been improved improved by reducing the beam spread from the antenna, and optimizing the placement of the antenna on the body.