In an injured patient, chest tube insertion may be lifesaving. It facilitates the evacuation of fluids, prevents the development of tension pneumothorax or tamponades and promotes lung re-expansion while improving respiratory function . In civilian trauma practice, the American College of Surgeons recommends needle decompression of tension pneumothoraces at the second intercostal space in the midclavicular line during the primary survey. This should be immediately followed by formal chest tube placement, with placement of a large-bore catheter . However, the use of this approach seems to have developed in the absence of a sound evidence base for efficacy and was probably advocated and has been used widely because of ease of access. This approach is time-consuming, requires training and expertise and has a high failure rate, both inside and outside of the hospital setting [9, 10]. An alternative approach beyond the conventional one is definitely needed. The ThoraXS device was designed to provide a safer, blade-free, rapid and easy-to-use method for chest tube insertion, and we believe it has the potential to revolutionize the way chest trauma patients are managed. Patients with an indication for chest tube placement present in several ways—while some have clear clinical indications for immediate chest tube insertion (respiratory or hemodynamic instability/penetrating chest wound injury), others present with a degree of stability that allows the physician to seek optimal conditions. The use of the ThoraXS device, if proven effective, would potentially facilitate pre-hospital treatment of tension pneumothorax, replacing the ineffective needle decompression method. Moreover, the ThoraXS device may impact the threshold for intervention towards pre-hospital chest tube placement even in more stable patients that bear a clear indication for chest tube. It may also prove to be efficacious for the management of different pathologies as it can be easily positioned facing the lung apex for ideal drainage of air (in case of pneumothorax) or otherwise facing the lung base for a more effective drainage of blood (in case of hemothorax). Its unique structure and mechanism of action makes it easy to apply to patients of different body sizes and ages (pediatric and adults).
Our clinical experience with the device is still limited, and essential information on the operating characteristics and reliability of the device are yet to be determined. Nevertheless, our main aim at the current stage of development is proof of concept. Further experiments and clinical trials are required to support the superiority of the ThoraXS device over conventional chest tube insertion in terms of safety and efficacy. Similar to the conventional chest tube insertion technique, use of the ThoraXS device carries a potential risk of injuring intercostal and intrathoracic vasculature, as well as internal organs in the chest or abdomen. It is essential that medical teams receive proper training that focuses on general peri-procedural, operative, and safety-oriented aspects before attempting to use the device.
The device is currently in its final design and development stage. Our next step is to conduct a larger-scale pre-clinical trial in an animal model, and then proceed to a clinical trial. The safety profile, efficacy and healthcare economic benefit remain to be demonstrated.