One of the best advantages when starting a company is ignorance. Ask Pramod Bonde, MD, an associate professor of surgery, and a recipient of the 2023 Yale Faculty Innovation Award. His project targets harmful reflux and aspiration in patients who are intubated and supported by mechanical ventilation.
“I always say that ignorance is an opportunity because if you don't know anything it forces you to look at the old problems in a novel way. We assume that solutions are complex. But solutions are extremely easy. It's asking the right questions that is complex. And that's exactly what we did,” said Dr. Bonde.
Dr. Bonde founded PiroGon Inc. in 2022. For two decades he studied the interaction of electromagnetic spectrum with biological systems and how gastroesophageal reflux leads to aspiration related lung injury. During the COVID pandemic he served in the Intensive Care Unit (ICU) using a heart-lung machine called ECMO (Extra Copper Membrane Oxygenation Support). The experience inspired a novel electromechanical approach to treat aspiration-related lung injury due to acute gastroesophageal reflux.
An ECMO machine removes carbon dioxide and returns oxygen-filled blood back to the body. “Every other heart surgeon in the country pitched in during the COVID pandemic. There was a lot that we learned through that process,” he said.
After the initial viral insult, over 50 percent of survivors continued to get lung injury due to aspiration of gastric contents while on ventilator hampering recovery, leading to ventilator associated pneumonia. When looking at non-COVID patients needing ventilatory support, this also poses risk if they were to need ventilatory support for more than 48 hours.
“The stomach contains a highly acidic solution to digest food. The lower esophageal sphincter prevents backward flow of this gastric contents. However, this lower esophageal valve becomes dysfunctional when patients receive sedatives, opiates, and anesthetic agents to help them tolerate the breathing tube which is inserted to help them breath on a ventilator,” said Dr. Bonde. This allows gastric contents to spread and spill over into the lungs causing injury. To prevent this injury a patient’s head at the end of bed is raised 30 to 45 degrees. This may not happen consistently due to low blood pressure or procedures where the patient lies flat. Antiacids lead to bacterial overgrowth due to reduced acidity and randomized clinical trials have shown that promotility drugs are ineffective at preventing aspiration related lung injury. Current guidelines for preventing aspiration-related lung injury requires additional training for ICU staff.
“This was a problem that was there for all along. We do a successful surgery, only to lose the patient because they get aspiration related lung injury, and they go on to develop ventilator-associated pneumonia,” said Dr. Bonde. Despite the availability of anti-acid drugs, ventilator-associated pneumonia is a recurring cause of morbidity and mortality. “There are many surgical and endoscopic ways of regaining the control, but none of those options are available for what we call acute reflux in patients,” he added.
Aspiration can lead to ventilator associated pneumonia, which is associated with 1 in 25 deaths in ventilated patients. Each year in United States, 15 million patients undergo insertion of a breathing tube in operating rooms. Outside of operating room another 650,000 breathing tubes are inserted in the hospital and 350,000 in the emergency room to prevent aspiration. “This is the most vulnerable population of patients because they can't speak for themselves and they're dependent on healthcare providers to be their advocate,” he said.