Evaluation of a Novel Needle Decompression Device Against Standard of Care: A Cadaveric Model

Abstract

ABSTRACT Introduction Pneumothorax (PTX) incidence in patients arriving to a trauma center can be as high as 20%. The severity of PTX can range from insignificant to life-threatening. Five percent of combat casualties sustaining thoracic trauma have tension PTX (tPTX) at the time of death. Rapid diagnosis and decompression, traditionally with a needle decompression in the prehospital setting, is essential. However, high iatrogenic injury rates reveal a need for a device with the potential to decrease injury rate without compromising decompression success. The Donaldson Decompression Needle (DDN) is a 10-gauge × 3.25 inch needle with a locking mechanism designed to prevent over-insertion. During insertion, a spring-loaded blunt tip retracts, releasing the lock. After penetration of the parietal pleura, the blunt tip projects forward, which in turn locks the device in place on the chest. The device also contains an integrated 1-way valve (OWV) to prevent causing iatrogenic PTX, if placed into a healthy lung cavity. Materials and Methods We compared the DDN against a standard-of-care (SOC) needle (E-ARS 10 gauge × 3.25”) in a cadaveric randomized crossover design study. Tension pneumothorax was created by inserting a needle adjacent to the sternum and insufflating to 15 mmHg. Data collected included participant demographics/experience, cadaver measurements, and procedure data such as intrathoracic pressures and decompression time. Participants also completed a postprocedure survey. A secondary objective was evaluation of decompression rate with the OWV on vs. off. Results Twenty participants were enrolled in the study. Five participants required exclusion. While there were no differences in set-up times for the 2 procedures (DDN vs. SOC, 33 seconds vs. 28 seconds, P = .63), the decompression times were significantly different between the 2 groups (DDN vs. SOC, 2:06 vs. 1:06, P = .019). Evaluation of the secondary outcome resulted in 18 repetitions. The average decompression time for the OWV on group (n = 9) vs. OWV off group (n = 9) was 44 seconds vs. 10 seconds (P=<.05). Conclusions Despite the similar length and gauge of the DDN compared to the standard of care (SOC), the success rate of thoracic decompression was lower for the DDN when compared to the SOC (46% vs. 87%, P = .077) although statistical noninferiority was not established. Additionally, intradevice comparisons indicated decompression with the OWV on significantly prolonged decompression time when compared to when it was removed. It could be appropriate to consider removing the OWV after placement to decrease the decompression time, followed by reattachment for transport. Further research into the ability of the DDN to decrease iatrogenic injury will follow validation of decompression capabilities.