With mechanical ventilation, sometimes a “battle” between the ventilator and patients ensues, with some fighting the device’s attempts to breathe for them even though they cannot breathe on their own.

Maquet Critical Care (Bridgewater, New Jersey) is banking on a mind-body connection of sorts, having reported earlier this week that they have received FDA clearance for their NAVA (Neurally Adjusted Ventilator Assist) technology for optional use with the company’s Servo-i ventilator, which has been in use in some form since the 1970s, according to the company.

The NAVA technology detects respiratory signals sent from the brain to the diaphragm — at least in those cases where the brain-to-diaphragm electrical signal is intact —and transmits those signals to the Servo-i ventilator.

“Basically, what NAVA does is it improves the synchrony between the patient and the ventilator,” Ed Coombs, product manager for Maquet, told Diagnostics & Imaging Week. “Too often when ventilators try to breathe for patients, and the patient’s breath-taking is not in synch with that [ventilator’s] parameters . . . normally what happens is that patient has to be paralyzed or sedated with pharmaceuticals . . .”

But with NAVA, which can be used in neonatal, pediatric or adult patients, the key is that the patient is controlling the breathing. Maquet hopes that this new add-on device for its Servo-I ventilator will shorten the patient’s time on the device as it more naturally facilitates breathing and presents less of a need for sedation.

“That’s one of our optimal goals,” Coombs said.

Conventional mechanical ventilators monitor airway pressure, flow or volume to initiate assistance and regulate their level of support. Such variables require greater patient effort with increasing ventilator “dysfunction,” Maquet said. Instead of responding to those variables, NAVA “senses the electrical activity of the diaphragm and regulates breath delivery from that signal known as Edi.”

Edi, or the electrical activity of the diaphragm, is the “earliest respiratory signal that can be detected in a patient,” Maquet said. The Edi signal is obtained by an electrode located close to the distal tip of the Edi catheter and fed to the ventilator.

The company said that these signals, which originate in the brain’s “respiratory control center,” travel through the phrenic nerve to the diaphragm, resulting in a “coupling between the two that is virtually instantaneous.” NAVA, it said, relies on a series of microelectrodes that are embedded in a specially designed naso-gastric tube to detect the electrical activity that “excites” the diaphragm, and this signal is then amplified and transmitted to the Servo-I ventilator.

“With ventilator and diaphragm both responding to the same neural signal, NAVA represents a form of monitoring and assisted ventilation in which the patient’s respiratory center controls the mechanical support provided throughout each breath,” the company said.

The company said that the NAVA solution is expected not only to improve synchrony between the ventilator and patients, but also present no concerns over contraindication for insertion or exchange of a naso-gastric tube.

Coombs told D&IW that Maquet, which is part of the Getinge Group (Stockholm, Sweden) and offers products for operating rooms, will be marketing to hospitals, intensive care units, physicians, respiratory therapists, i.e., “anyone that plays a role in clinical care.”

“Our rollout, because it is a very big paradigm shift from what we’ve done conventionally for the past 30 years, is to have a slowly [presented] introductory rollout at reference sites in the four corners of the country, so to speak,” Coombs said.

As a result of that rollout, the company hopes to gain additional experience with both patients and clinicians, offering both a chance to experience the NAVA approach for themselves. Those reference centers are expected to be in California, Missouri, Virginia and North Carolina.

Maquet Critical Care began work on the NAVA with a research team at St. Michael’s Hospital (Toronto) in 2001.

“We are very excited to bring this technology to market, now that the FDA has provided a 510(k) clearance, and we think it will make a big difference in the lives of patients who are on mechanical ventilation,” Coombs said.