In the decades since ventilators first made their appearance in the ICU, they’ve evolved from machines that ran on manually calculated settings dialed in by respiratory therapists to high-tech devices that utilize software to manage ventilator function and get the right mix of pressure flow and volumes for each patient.
But the challenges of lung injury, infection, and weaning remain. In recent years, strides have been made to address these issues, including manufacturers returning to creating neonatal-specific platforms in addition to infant-to-adult models. Both have been improved with features designed to better outcomes and enhance patient safety, connect to electronic records systems and make the devices easier to use.

Prioritizing patient safety
Enhancing patient safety is the goal with all mechanical ventilators, including adult devices, with features such as prioritized alarm messages, troubleshooting guides embedded in the user interface, and customizable data displays, says Edwin Coombs, director of marketing for intensive care and neonatal care with Draeger Medical.

Automated weaning software is also now common, such as the Smartcare/PS in Draeger’s V500 ventilator, and others, including Hamilton Medical’s Adaptive Support Ventilation, Covidien’s Proportional Assist Ventilation and Maquet’s Neurally Adjusted Ventilatory Assist. This technology can assess a patient’s readiness to wean from mechanical ventilation and alter the level of support according to the assessment of physiologic parameters. “The result is a reduction in weaning time and length of admission in the ICU, which can translate into a significant cost reduction and greater customer satisfaction,” Coombs says.

Another trend is improving workflow design through mechanical ventilation. For example, Draeger ventilators have the capacity to deliver invasive ventilation, non-invasive ventilation, which other manufacturers offer, as well as oxygen therapy, so caregivers can use one device, decreasing the amount of disposable circuits and avoiding clutter at the bedside, which Coombs says improves efficiency and reduces cost of care.

Despite the strides made, however, especially with the advent of complex algorithms in the latest ventilators on the market, expert knowledge is still crucial to successful outcomes, says Dr. Aliaksei Pustavoitau, medical director of respiratory care services at The Johns Hopkins Hospital in Baltimore, who is now testing four of the newest models from leading ventilator manufacturers, including Covidien, Draeger, GE, and Hamilton Medical, “to see if they do what they claim,” Pustavoitau says. His institution is looking to replace its aging ventilators in the next five years. He feels that the biggest change he has seen from older machines to the latest ones is that “the computer and processing power has become different,” Pustavoitau says. “That’s where the greatest range of possibilities lie.”

Shift to two types of ventilators
Infant-to-adult ventilators are attractive because they offer one user interface for staff to become familiar with, and also make maintenance easier, says Kathey Leibold, an analyst with MD Buyline. But one-size machines definitely do not fit all. A machine must deliver volume and pressure specifically for the micro-preemie, and must also compensate for leaks, since the endotracheal tubes used on the infants don’t have cuffs, in an effort to prevent damage to the airway. Monitoring, alarms, and settings must also be designed for the smallest of patients. Respiratory therapists have found that even machines with neonatal or infant software aren’t always the best choice, Leibold says.

“You really need a dedicated ventilator that is designed specifically and only for those really tiny patients,” Leibold says. “A tiny preemie is not the same as an adult.” Staff in neonatal units have also historically preferred to keep their machines inside the NICU, to avoid potentially spreading infection to some of the most vulnerable patients.

There are a number of exciting options now on the market, as a number of makers now have neonatal-only machines. Draeger introduced the Babylog VN500, a neonatal/pediatric specific ventilator, in 2010. It offered “easy-to-read data and graphics, alarm messages, and parameter screens,” says Coombs, adding that these “were paramount features for the neonatology group.”

Data management was also a key issue for hospital IT departments, and with the VN500, a comprehensive set of patient values, alarms, settings, and waveforms can be exported to a variety of information systems and physiologic monitors.

One plus was its interface. The VN500 has much in common with Draeger’s infant-to-adult V500 ventilator, including a similar user interface and hardware components, though there are some differences. The VN500 has infant-specific features, including an optional control for leakage compensation, while the V500 has specific adult applications, such as automated weaning protocol.

There may be additional changes to the neonatal machine to allow it to be even more specifically tailored for the youngest patients. “As technology and market clearance for infant-specific features of the VN500 move forward over time, there will be more differentiation between the two models,” Coombs says.

Another developing trend in neonatal ventilation is the use of volume guarantee ventilation, Coombs says. Studies have shown that infants who receive volume ventilation versus conventional pressure ventilation tend to have less variation in C02 values, potentially less intraventricular hemorrhage, and a lower incidence of bronchopulmonary dysplasia and other lung-related injuries. “To be successful in using this mode of ventilation, proper monitoring of tidal volumes and airway leakage is essential,” Coombs says.

Covidien staked its claim in the neonatal ventilation market with its Puritan Bennett 980 ventilator, including a neonatal platform, in the U.S. in 2014. The neonatal ventilator comes with infant-specific applications such as Leak Sync software, which automatically detects and compensates for fluctuating leak sizes, as well as presets that track the most relevant parameters in a particular instance. There is also the ability to use non-invasive synchronized intermittent mandatory ventilation, which may help reduce the need to use invasive approaches to ventilation with endotracheal tubes, says Gary Milne, director of clinical marketing for respiratory solutions with Covidien.

The Puritan Bennett 980 ventilator is another machine aimed at the youngest patient. It has safety features that include a 1 percent resolution change in an automated increase in oxygen, which automatically turns off so the neonate is not exposed to elevated levels beyond need, Milne says. Volume-based delivery, which needs to be accurate on small babies, is within 10 percent of what is set within one standard deviation and can deliver down to 2-millimeter tidal volumes. In pressure-based approaches, the milligrams per kilogram can now be monitored both on inspired and expired volumes, which allows for assessment of lung protective volumes in pressure-based modes.

Hamilton Medical showed its T1 full-featured transport ventilator and its C1 ventilator, which will offer neonatal applications, at last year’s American Association for Respiratory Care Congress. Maquet promoted its Servo-U neonatal-through-adult ventilator and the Servo-N, a dedicated infant platform at the same meeting. The companies’ machines are currently pending FDA clearance, according to Leibold, who wrote about the conference for MD Buyline.

GE Healthcare has added some unique features to its CARESCAPE R860 ventilator, a neonatal-to-adult model that is pending FDA clearance and is available in Europe only as of today. One such feature, called Metabolics, measures inhaled and exhaled gases, which the physician can use to assess a patient’s nutritional status, says Paul Hunsicker, clinical manager for GE Healthcare Life Care Solutions.

“No one tells you to carbo load before surgery,” Hunsicker says. “Fifty percent of patients have some form of severe to moderate malnutrition. Metabolics allows us to measure caloric requirements of patients so they can be fed appropriately. This can address issues with weaning and healing in some patients.”

The device also has a mode of ventilation called Spontaneous Breathing Trial, designed to help caregivers assess when patients are ready to come off mechanical ventilation and breathe on their own, to avoid the complications and costs that come with prolonged ventilation.

The CARESCAPE R860 also has a touchscreen user interface designed to simplify the navigation process using technology that’s similar to what users are familiar with seeing in phones and tablets. The company has also developed features that may help reduce ventilator induced lung injury through the ability to measure functional residual capacity. “We’re trying to help people better understand the impact of the settings on the patient,” Hunsicker says. “When we think of patients in ICU, all these tools help mitigate or at least allow clinicians a way to reduce these issues and provide appropriate care.”

Dr. William Dinan, director of pulmonary medicine and medical director of respiratory therapy at the Henry J. Carter Specialty Hospital, a long-term acute care hospital in Upper Manhattan that specializes in patients who have trouble coming off of ventilators, says one manufacturer’s weaning mode has never been proven superior to another. Even these days, Dinan says, the respiratory therapist’s and the doctor’s knowledge of weaning, and knowing what caused the respiratory failure to begin with, have the biggest impact.

“When you add the bells and whistles of the high-tech stuff, the software, it doesn’t end up making a difference with respect to one high-end ventilator to the next one,” Dinan says.

‘All the difference in the world’
While ventilators have become more sensitive and more accurate, some are better than others for specific patients and clinical situations, says Robert DiBlasi, a respiratory therapist and neonatal pediatric specialist at Seattle Children’s Research Institute.

“What little difference there is, is all the difference in the world, and you need to take performance into consideration for all patients that you treat,” DiBlasi says. For example, they vary in detecting leaks and some are more sensitive to trigger, or the way a patient initiates a breath. New data is guiding the decision to ventilate with volume and to choose a ventilator that’s highly accurate in choosing these volumes, DiBlasi says.

The team at Seattle Children’s Research Institute evaluates performance in the laboratory and has provided ventilator manufacturers with input on how they can potentially improve their products. “Overall, clinicians should never assume one mechanical ventilator is better than the other,” DiBlasi says. “Our research has shown that there are disparities in performance and safety. Although most of these ventilators undergo similar testing for 510(k) clearance, they don’t take into account all patient populations that could be potentially supported by this.”

DiBlasi advises facilities, when purchasing ventilators, to make sure the company provides good technical support and that it is willing to work with clinicians or end users on performance. “Try to select a company you know is willing to work with you,” DiBlasi says. “It’s not simply a point of sale. It’s more, how am I going to develop an ongoing relationship?”

Making a connection
Connectivity is important for all medical devices, and can impact ventilator purchase decisions. Pustavoitau, of Johns Hopkins, says one of the most important questions to ask a vendor is how the ventilator integrates into hospital IT systems, and about the device’s ability to communicate with the facility’s current monitoring systems.

Ventilator manufacturers have been working with hospitals that purchase their products to make sure they interface with EMRs, says Leibold of MD Buyline. Covidien, for example, has an EMR interface solution called the Vital Sync Virtual Patient Monitoring Platform, while CareFusion offers Knowledge Portal, which connects ventilators to hospital IT systems.

“Like everything in a hospital, it has to be connected and it has to be connected seamlessly,” Leibold says. “Between two ventilators, one that works best with their information system is one they choose.”