MOBILE, Alabama (Oct. 10, 2024) — Research shows that patients whose breathing is supported by a ventilator for an extended time are at higher risk of losing strength in the diaphragm, the major muscle of respiration, and developing a life-threatening infection such as pneumonia.

Maryann Mbaka, M.D., a trauma and emergency general surgeon at USA Health University Hospital, is studying a new way to help these patients regain the strength they need to breathe on their own more quickly – potentially avoiding infection and death.

USA Health is one of 18 sites in the nation enrolling patients in the ReInvigorate Study, which will evaluate the safety and efficacy of the pdSTIM System to increase diaphragm strength and improve ventilation weaning for patients when compared with the standard of care.

“This research focuses on the stimulation of the phrenic nerve – which controls the diaphragm – as a way to wean critically ill patients off ventilatory support,” said Mbaka, who also serves as an assistant professor of surgery at the Frederick P. Whiddon College of Medicine at the University of South Alabama. “Patients with acute respiratory failure can experience many complications associated with critical illness and prolonged hospitalization; therefore, having any means to improve the care of those patients and expedite ventilatory wean will not only improve the care of the patients, but also improve outcomes.”

Developed by Stimdia Medical for use at the bedside, the pdSTIM System is indicated for ventilated adults who have been on mechanical ventilation for at least 96 hours and have failed at least one weaning attempt. To employ the system, a provider inserts a temporary pacing lead into a small incision in the patient’s neck, and a nearby console recognizes the onset of the patient’s inhalation and stimulates the phrenic nerve through the lead, causing the diaphragm to contract.

Studies have estimated that more than 300,000 patients receive mechanical ventilation in the United States each year, according to the Centers for Disease Control and Prevention. Pneumonia, sepsis, acute respiratory distress syndrome, blood clots and fluid buildup in the lungs are among the complications that can occur in patients receiving mechanical ventilation.

Mortality in patients with acute lung injury on mechanical ventilation has been estimated to range from 24% in people ages 15 to 19 to 60% for patients ages 85 and older.

Mbaka said critically ill patients admitted to the intensive care unit at University Hospital who fail to wean from the ventilator per protocol will be evaluated for this study after appropriate consent is obtained.