BBI Contributing Writer

SAN ANTONIO, Texas — Intriguing scientific presentations and new technology introductions vied for the attention of some 5,200 respiratory care practitioners during the American Association for Respiratory Care's (AARC; Dallas, Texas) 47th annual congress, held just down the street from the historic Alamo this past December.One of the more interesting presentations given at this congress was delivered by Nader Habashi, MD, an assistant professor at the University of Maryland School of Medicine and director of the multi-trauma intensive care unit in the University of Maryland Medical System (Baltimore, Maryland). Habashi combined with his colleague at the shock trauma unit, Thomas Scalea, MD, via a live video link to take the convention attendees inside the critical care ICU for a look at the newest therapies being used there for treatment of acute respiratory distress syndrome, acute lung injury and multi-system organ failure.

Habashi also is the founder and CEO of the Intensive Care On-Line Network (ICON; Linthicum, Maryland), which provides clinical support and education for intensive care practitioners via the telephone and Internet. ICON also offers advanced learning modules, informational literature, training materials and an interactive web site. During the conference, Draeger Medical (Telford, Pennsylvania) announced a partnership with ICON whereby for a limited time all purchasers of an Evita ventilator from Draeger will receive a certain amount of on-line advanced clinical support from ICON.

Another presentation well worth attending was delivered by Richard Branson, an associate professor in the department of surgery in the Division of Trauma and Critical Care at the University of Cincinnati Medical Center (Cincinnati, Ohio). Branson described the parallels between the evolution of mechanical ventilators and the growth in intensive care medicine. He gave his audience a tour through the historical design of mechanical ventilators and discussed future changes that should be anticipated and welcomed. His presentation was especially timely, since several manufacturers introduced new ventilators during the AARC meeting, while others offered software upgrades to their existing units, thus expanding their clinical capabilities.

The four-day conference was highlighted by the plethora of new technologies introduced to the respiratory therapists and their medical directors by the innovators among the 260 exhibitors.

New ventilators ignite interest

The new product introduction that engendered the most interest at the convention was the Avea critical care ventilator from Viasys Healthcare (Conshohocken, Pennsylvania). Marketed under the Viasys name, this unit, for which 510(k) approval is pending, is the first adult-to-neonate critical care ventilator for the company. Viasys Healthcare markets and manufactures several different adult/pediatric and neonate/infant ventilators under its Bird Products, Bear Medical Systems and SensorMedics Critical Care subsidiaries. The Avea ventilator is a microprocessor-controlled unit that has a full color graphics monitor and an extensive data communication capability. The unit's ergonomic design and intuitive user interface will make it easy for clinicians to operate. This is important because the Avea offers all of the currently available clinical modes of operation, including noninvasive ventilation. Its most intriguing feature is that all the modes for neonatal, pediatric and adult ventilation are included with purchase of the unit. Clinicians especially will appreciate the ability to deliver helium/oxygen mixtures in addition to room air or oxygen-enriched gas and the ability to have tracheo-esophageal pressure monitoring. In the U.S. this unit will compete with the companies listed in Table 1. U.S. hospital ventilator market size for 2000 is summarized in Table 2.

Viasys also introduced the SensorMedics Model 3100B High Frequency Oscillatory Ventilator for treatment of acute respiratory distress syndrome (ARDS) in adults and large children. The unit is similar in design and function to its highly successful 3100A unit, designed for use with infants and small children. The new 3100B unit allows the application of continuous distending pressures of up to 55 cmH20 to open diseased portions of the lung and increase oxygenation. Simultaneously, the ventilator also delivers 180 to 900 breaths per minute at a small tidal volume to remove carbon dioxide and prevent injury to the lung. The ventilator is easy to operate and comes equipped with a wide variety of alarms, indicators and displays. Since the annual incidence of ARDS is 100,000, there is a large potential market for this device. Viasys Healthcare will use its highly successful strategy of offering this device to hospitals through either a purchase or rental program. Both units use a proprietary patient circuit available only from the company. An overview of the market for U.S. specialty application ventilators is shown in Table 3.

Another new ventilator that generated enormous interest at this meeting was the Servoi from Siemens Medical Systems (Danvers, Massachusetts). This new ventilator, for which 510(k) approval is pending, is smaller and more compact than the current Model 300. The unit is microprocessor-controlled, has an upgradeable platform and can be used for neonates through adults. The major feature of the unit is its ability to be configured to the specific needs of the hospital. The ventilator can be used in transport and to deliver noninvasive ventilation.

New entrant in noninvasive ventilation

The adult market for noninvasive ventilation in the hospital is currently dominated by Respironics (Pittsburgh, Pennsylvania), with its S/T-D 30 and Vision units. Until this meeting, Respironics had no competition in a market that is worth $18 million in revenues to the company and that is expected to grow at a compounded annual growth rate (CAGR) of at least 16% over the next five years. A unit from Puritan Bennett (Pleasanton, California) was introduced at AARC that will try to challenge Respironics' leadership. Noninvasive ventilation is assisted ventilation without the use of an endotracheal or tracheostomy tube. When noninvasive ventilation is used, patients are spared the necessity of intubation, mechanical ventilation and sedation.

The unit from Puritan Bennett is the KnightStar 330. Its intended use is in the hospital, sleep lab and at home. Its specifications are similar to the ST-D 30, but it claims to be a smaller and quieter unit. The unit was to be released early this year.

Infant CPAP market undergoes changes

The use of continuous positive airway pressure (CPAP) is commonly used in neonatal care to restore the functional residual capacity and correct hypoxemia. CPAP is commonly used with infants in the delivery room, in intermediate care units and level three infant ICUS. The most popular unit to deliver CPAP is the Infant Flow System made by Electro Medical Equipment Ltd. (EME; Sussex, England). The Infant Flow System is not new to the U.S. market. This same unit was previously marketed in the U.S. by Hamilton Medical (Reno, Nevada) and Viasys. In mid-2001, EME decided to sell the Infant Flow System in the U.S. using its own direct sales organization, and in October 2001 it entered into a distribution agreement with Allegiance Respiratory Care (McGaw Park, Illinois). The unit is clever in design and incorporates a single limb-heated wire patient circuit. Each patient uses a disposable single limb patient circuit, generator, nasal CPAP mask and bonnet. Profitability is driven by initial unit sales, with a strong aftermarket for the disposables. The aftermarket is so lucrative that Viasys Healthcare introduced at AARC its own brand of infant circuits that work with the Infant Flow system.

EME leads in this market segment, followed by Hamilton Medical, while Viasys and Caradyne (Indianapolis, Indiana) are expected to introduce competitive units this year.

Updates, add-ons expand usage

The most significant product update was the announcement by Puritan Bennett that it was releasing for sale the long-awaited NeoMode option for the Model 840 ventilator. This new clinical option will allow the Model 840 to ventilate from neonates to adults. The key feature of the NeoMode is that it requires no proximal airway sensor. Having a critical care ventilator that can ventilate neonates through adults has become a marketing advantage, since Draeger has that capability with its Evita 2 Dura and Evita 4 unit, as do Siemens with its 300 A and B ventilators and Hamilton with its Galileo ventilator.

Respironics announced the release of several new products for the Esprit ventilator. The first is an oxygen manifold for the back of the Esprit that will allow the unit to be used for transport. The oxygen manifold will allow the clinician to disconnect the unit from wall oxygen and switch over to E cylinders mounted on the system. An external battery for the Esprit allows it to operate for two hours. New respiratory mechanics software for the Esprit was shown that, when available — 510(k) approval is pending — will allow the clinician to complete a series of weaning parameters, such as vital capacity, negative inspiratory force or maximal inspiratory pressure, compliance and resistance in both static and dynamic values and rapid shallow breathing index. Auto-Trak sensitivity is another software update that also will soon be available for users of the Esprit ventilator. It provides leak compensation up to 60 l/min and optimal trigger sensitivity during routine mechanical ventilation and noninvasive use.

Another not-yet-approved product shown by Respironics was the ViewLink interfacing capability. This unit combines new proprietary software for the Hewlett-Packard Open Protocol Module. This allows the output data from the Esprit ventilator to interface with the HP ViewLink to display minute volume, peak inspiratory pressure, mean airway pressure, tidal volume and waveforms. Operating the ViewLink with the Esprit ventilator requires a computer interface cable and a software update. These are expected to be available in March.

Remote surveillance/wireless monitoring

Sicker and sicker patients are being discharged to step-down units and routine patient floors to free up costly ICU beds. These patients often need remote monitoring. The challenge is to alert the caregiver immediately of an alarm condition that demands immediate intervention. Two manufacturers have introduced different solutions. Cardiopulmonary Corp.'s (Milford, Connecticut) solution is the Bernoulli Ventilator Management System. The device uses web- based and wireless technologies to interface with and provide remote surveillance of ventilators that have RS-232, ethernet or nurse call via a central station. This data is also available remotely through alphanumeric pagers or hand-held devices, thus enabling clinicians to respond quickly to an emergency whether they are responding from the central station or by being notified remotely. Cost is expected to be $2,500 to $3,000 per bed. Remote monitoring of oximetry devices will be available in 1Q02. Bernoulli can also be used for advanced data storage and retrieval. The device can monitor all transmitted ventilator information and translate it into information that can be used at the central station or via the hospital's intranet. Clinicians can view data using their computers at remote locations.

A similar product, the FlexView Clinical Network System from GE Medical Systems Data Critical (Waukesha, Wisconsin), was shown at AARC. It too is a central station device that alerts nurses and respiratory therapists remotely through alphanumeric pagers or hand-held devices of device alarms, patient trends and device operational problems, thus minimizing delayed or missed alarms. It differs from Bernoulli in that it works with ventilators, oximeters and IV pumps to provide a single, integrated view of the patient. Cost is expected to be $2,000 per bed.

These systems are costly to implement per bed, but they offer the ability to remotely monitor more than one piece of equipment in the same patient's room. They also offer the ability to simultaneously monitor several patients. These systems will compete with the remote-only oximetry notification systems of alphanumeric pagers or hand-held devices available from manufacturers such as Puritan Bennett and Criticare Systems (Milwaukee, Wisconsin) and the various remote alarm units available with most mechanical ventilators. Until now, the remote ventilator alarms have been limited to nurse call lights that were illuminated over the patient's doorway. The activation of the light could have meant a life-threatening condition, a less-threatening situation or a nuisance alarm, but all had to be treated as an emergency and responded to accordingly. These two new systems address that problem.

Other vendor announcements

Advanced Respiratory (St. Paul, Minnesota) displayed its new Chest Vest. The system consists of an inflatable vest connected by hoses to an air-pulse generator. The generator is used to rapidly inflate and deflate the vest. This action compresses and releases the chest wall. Clinically this is termed high-frequency chest wall oscillation. This technique generates increased airflow velocities that create repetitive cough-like forces inside the lung while simultaneously decreasing the viscosity of secretions. These two effects increase secretion mobilization. The new Vest device has a change in design for patients with COPD that eliminates abdominal pressure, thereby increasing patient comfort, which in turn improves compliance. The vest is fully adjustable and flexible to meet different patient sizes.

The Vest system is currently in use by more than 15,000 patients with cystic fibrosis and more than 19,000 patients in total. Treatment of patients with the system provides the company with a major growth opportunity since chronic obstructive pulmonary disease (COPD) ranks among the leading causes of adult morbidity and mortality in the U.S. COPD is currently the fourth-leading cause of death in the U.S. An estimated 16 million Americans have COPD.

BCI SIMS (Waukesha, Wisconsin) showed its new Digital Pulse Oximeter for spot-checking of oxygen saturation and heart rate. The unit, not yet 510(k) cleared, is compact, measuring only 1.5" x 2.5". It connects to a lanyard that can be worn around the neck by respiratory therapists or nurses. The unit is powered by two AAA batteries and automatically turns itself off after eight seconds to conserve battery strength. This unit will compete in the marketplace with Nonin Medical's (Plymouth, Minnesota) Onyx device.

Bunnell (Salt Lake City, Utah) showed its new WhisperJet Patient Box, for which a PMA supplement is pending. The device will replace its existing Patient Box and offers a much quieter operation. The WhisperJet Patient Box allows the inhalation valve and pressure transducer to be placed close to the patient. This proximity makes the small high velocity breaths more effective and allows accurate pressure monitoring. In addition to the WhisperJet Patient Box, the company said it is working on a redesign of its Life Pulse ventilator

DHD Healthcare (Canastota, New York) introduced its new disposable patient circuit that allows aerosol delivery without removing the HME that is used for humidification. The circuit should be well-received by clinicians because it should decrease the incidence of nosocomial infections that often ensue when the patient circuit is broken to remove the HME. The circuit also maintains the integrity of the positive expiratory pressure (PEEP) level. PEEP is used by clinicians to increase oxygenation in patients. It also reduces the incidence of clinicians inadvertently forgetting to replace the HME following the delivery of the aerosol therapy.

Impact Instrumentation (West Caldwell, New Jersey) showed its new Model 100 Performance Analyzer. This product is designed for use by biomedical engineering personnel to measure devices that use pressure and flow. The device can display up to four different graphic waveforms in color simultaneously, can freeze and print graphics and download the information to a personal computer. It also has dual inputs to allow the user to develop calibration software for various devices. This unit will compete in the marketplace with units from Metron (Trondheim, Norway), Puritan Bennett and Allied HealthCare (St. Louis, Missouri) and will be available in April.

Maxtec (Salt Lake City, Utah) introduced a portable ventilator called the MaxO2Vent. The compact device is pneumatically powered and weighs only 4.5 pounds. The unit can be used with infants through adults in a wide variety of clinical environments, such as in a magnetic resonance imaging unit, special procedures room or for routine patient transport via ambulance or air. The device was designed and is being manufactured for Maxtec by Oceanic Medical (Atchison, Kansas).

Pulmonetic Systems (Colton, California) showed its new LTM Graphics Monitor for use with the LTV series of ventilators. The slender color monitor allows the clinician to view critical patient-ventilator information while providing continuous monitoring. This device will greatly expand the clinical capability of the LTV series. The monitor allows the clinician to display in real time pressure, flow and volume waveforms; ventilator settings and monitored values; pressure-volume loops or flow-volume loops; trends for all monitored values; reference breath to future breaths and a summary display of information on one screen.

Respironics also showed its upcoming Humax Humidification system. This humidifier will compete with market leader Fisher Paykel (Laguna Hills, California) and Hudson RCI (Temecula, California). The unit incorporates all of the alarms and indicators required clinically. The humidifier connects to a bundle of 32 micropore capillary tubes that wrap around a heated wire. The sterile water supply is then fed from an IV bag through an IV pump directly into the patient circuit. As the patient circuit is heated, the water vaporizes through the micropores and is delivered to the patient.