A novel method to detect thoracic and abdominal injuries - The microwave belt and bioimpendance measurements.
Background
With 5.8 million deaths per year, injury accounts for 10% of global mortality. Traffic accidents and falls at home are common causes. Mortality/morbidity can be reduced if right treatment is provided faster; the key is to bring diagnostic solutions to the prehospital field. Internal injuries to the torso pose a high risk of death and are difficult to diagnose in the prehospital setting. Of considerable concern are punctured lungs (pneumothorax), thoracic bleeding (hemothorax) and abdominal bleeding (hemoperitoneum). These conditions are potentially lethal because PTX can develop into a tension PTX and bleeding in both the chest and abdomen can lead to exsanguination.
Objective
In this project, we intend to evaluate the use of microwave technology combined with bioimpedance to diagnose and monitor the target injuries, and measure vital signs such as heart rate, respiratory rate and hemodynamics.
Method
The project is based on the use of a realistic animal porcine model, microwave and bioimpedance technology. Pilot tests of two pigs at the SEARCH animal lab in August 2014 (Application ID 6850) have yielded promising results and have received attention from world leading experts. We now intend to extend the pilot study to measure 20 pigs to obtain proof-of-concept. The non-invasive diagnostic measurements with microwaves and bioimpedance are totally unharmful. To experimentally induce pneumothorax, hemothorax and hemoperitoneum we will use an already developed porcine model (Application ID 6850). We will make small surgical incision in the chest and insert a catheter into the pleural cavity. Through this catheter we will first insufflate air around the lung (pneumothorax) and then measure with the microwave belt and bioimpedance. The next stage is to insert fluid/blood into the same catheter (hemothorax) and repeat the measurements. Finally we will insert a catheter into the abdominal cavity and insert fluid/blood (hemoperitoneum) and repeat the same measurements in the abdomen. All animals will be anesthetized according to a well established protocol and local anesthetics will be used before every surgical incision.
The 3 "R"
The trial will follow the concept of the 3 "R´s". This novel diagnostic method cannot be tested directly on humans or on a simulator (mannequin). This is a concept study where we based on experience from previous studies estimate that 20 pigs is a minimum to capture inter-individual anatomic variability to be able to do a proper statistical analysis, and develop diagnostic algorithms. All animals are utilized to their full extent and both the chest and abdomen measurements are done after insertion of air and fluid/blood.
Expected results
Next, we will verify a window in market for the potential product, and further develop the microwave laboratory prototype into a product prototype that can be combined with bioimpedance. The product prototype will be evaluated in user tests with ambulance crews. If this project is successful it paves the way for clinical trials and commercialization. Since trauma is one of the largest global public health problems there will be a big interest worldwide for such a product, for both civil and military customers.
With 5.8 million deaths per year, injury accounts for 10% of global mortality. Traffic accidents and falls at home are common causes. Mortality/morbidity can be reduced if right treatment is provided faster; the key is to bring diagnostic solutions to the prehospital field. Internal injuries to the torso pose a high risk of death and are difficult to diagnose in the prehospital setting. Of considerable concern are punctured lungs (pneumothorax), thoracic bleeding (hemothorax) and abdominal bleeding (hemoperitoneum). These conditions are potentially lethal because PTX can develop into a tension PTX and bleeding in both the chest and abdomen can lead to exsanguination.
Objective
In this project, we intend to evaluate the use of microwave technology combined with bioimpedance to diagnose and monitor the target injuries, and measure vital signs such as heart rate, respiratory rate and hemodynamics.
Method
The project is based on the use of a realistic animal porcine model, microwave and bioimpedance technology. Pilot tests of two pigs at the SEARCH animal lab in August 2014 (Application ID 6850) have yielded promising results and have received attention from world leading experts. We now intend to extend the pilot study to measure 20 pigs to obtain proof-of-concept. The non-invasive diagnostic measurements with microwaves and bioimpedance are totally unharmful. To experimentally induce pneumothorax, hemothorax and hemoperitoneum we will use an already developed porcine model (Application ID 6850). We will make small surgical incision in the chest and insert a catheter into the pleural cavity. Through this catheter we will first insufflate air around the lung (pneumothorax) and then measure with the microwave belt and bioimpedance. The next stage is to insert fluid/blood into the same catheter (hemothorax) and repeat the measurements. Finally we will insert a catheter into the abdominal cavity and insert fluid/blood (hemoperitoneum) and repeat the same measurements in the abdomen. All animals will be anesthetized according to a well established protocol and local anesthetics will be used before every surgical incision.
The 3 "R"
The trial will follow the concept of the 3 "R´s". This novel diagnostic method cannot be tested directly on humans or on a simulator (mannequin). This is a concept study where we based on experience from previous studies estimate that 20 pigs is a minimum to capture inter-individual anatomic variability to be able to do a proper statistical analysis, and develop diagnostic algorithms. All animals are utilized to their full extent and both the chest and abdomen measurements are done after insertion of air and fluid/blood.
Expected results
Next, we will verify a window in market for the potential product, and further develop the microwave laboratory prototype into a product prototype that can be combined with bioimpedance. The product prototype will be evaluated in user tests with ambulance crews. If this project is successful it paves the way for clinical trials and commercialization. Since trauma is one of the largest global public health problems there will be a big interest worldwide for such a product, for both civil and military customers.