Image: Tablet display of EPAD patient status (Photo courtesy of SafeOp Surgical).
A novel device monitors anesthetized patients neurological status in a wide array of surgical procedures where full monitoring may not be indicated, cost effective, or feasible.
The Evoked Potential Assessment Device (EPAD) assesses the neuromuscular junction (NMJ) by recording somatosensory evoked potentials (SSEPs), which are particularly effective in revealing damage to peripheral nerves during surgery caused by the way the patient is positioned on the surgical table. Involuntary compressing or stretching of peripheral nerves, or compromised blood supply to the nerves, can all lead to damage if the patient’s position remains uncorrected. The condition is known as positioning effect.
By flagging SSEP changes that are consistent with positioning effect, the system allows caregivers to examine waveforms and adjust the patient’s position to avoid nerve injury during anesthesia. The EPAD displays real time waveform data and graphical displays gathered via surface electrode packages that allow selective monitoring of integrated NMJ testing, including train of four, single simulation, and post-tetanic count. Bluetooth wireless technology allows easy set-up, control, and integration of the system into current operating room practices. The EPAD is a product of SafeOp Surgical (Hunt Valley MD, USA), and has been approved by the US Food and Drug Administration (FDA).
“Positioning effect is likely under-diagnosed and, despite caregivers’ best efforts, can occur in a significant number of surgeries. Until now it has often been considered a cost of doing surgery,” said Richard O’Brien, MD, MBA, chief medical officer at SafeOp. “Where comprehensive neuromonitoring with a technician and neurologist is not indicated, but positioning effect or paralytic effect remains an issue, our system adds vital information at minimal cost.”
“We are excited to bring neurological monitoring to a greater population of surgical patients in the US market,” said Curt LaBelle, MD, MBA, president of SafeOp. “Just as cardiac function and respiratory function are monitored in surgical procedures, we believe that nerve function monitoring will become standard of care in the future, resulting in fewer adverse events for patients.”
Positioning effect occurs when the body is in certain positions for an extended period of time with the body’s weight compressing or stretching nerves or blood vessels; an example of PE is when you wake from sleep with a numb arm. When sleeping, the brain monitors nerve function and wakes you up before permanent damage occurs. When under anesthesia, however, the brain cannot wake you up, and damage can continue and become permanent. As surgeries become longer and more complex, and utilize sophisticated technologies such as robotic assistance, a greater potential for positioning effect exists.