Children can be at risk for compromised breathing after surgery or from conditions like asthma, congestive heart failure or sleep apnea. Opioid therapy and sedation for medical procedures can also depress breathing. Unless a child is sick enough to have a breathing tube, respiratory problems can be difficult to detect early. Yet early detection can mean the difference between life and death.
“There is currently no real-time objective measure,” says Viviane Nasr, MD, an anesthesiologist with Boston Children’s Hospital’s Division of Cardiac Anesthesia. “Instead, respiratory assessment relies on oximetry data, a late indicator of respiratory decline, and on subjective clinical assessment.”
A new device, recently cleared by the FDA for children 1 year and older in medical settings, provides an easy, noninvasive way to tell how much air the lungs are receiving in real time. It can signal problems as much as 15-30 minutes before standard pulse oximetry picks up low blood oxygenation, according to one study.
A wearable watchdog
Called ExSpiron, the device is essentially a wearable attached to a monitor. A pair of disposable electrodes stick onto the child’s chest and, similar to body fat measurements, send a small current through the chest. The device detects the amount of impedance or resistance the current encounters and thereby calculate the volume of air in the lungs with each breath.
ExSpiron was originally developed for adults. To encourage its adaptation for the much smaller pediatric market, the Innovation and Digital Health Accelerator at Boston Children’s Hospital provided support via the FDA-funded Boston Pediatric Device Consortium (BPDC).
A study led by Nasr, published in December in Anesthesia and Analgesia, tested the device in 72 children who received general anesthesia with endotracheal intubation. ExSpiron measurements agreed well with “gold standard” measurements from an in-line monitoring spirometer.
Invasive devices like the spirometer require a nose clip and a fitted mouthpiece or face mask. This makes them impractical for squirmy babies or young children. In contrast, ExSpiron is comfortable and less likely to be dislodged when a child moves around.
Down the road, the device could potentially be used in infants younger than one year, says Nasr, who received no compensation from the company for conducting her studies. She and a group of investigators are now testing the device in infants and newborns at Boston Children’s.