BBI Contributing Writer
TAMPA, Florida — Twenty years of progress in respiratory care was the focus of the more than 5,000 respiratory care practitioners and 200-plus exhibitors who attended the 47th annual congress of the American Association for Respiratory Care (AARC; Dallas, Texas) in October.
One area that has changed rapidly for respiratory therapists is in cardiopulmonary resuscitation. Charles Durbin Jr., MD, professor of anesthesiology and surgery at the University of Virginia Health Science Center (Charlottesville, Virginia), discussed the changes that have occurred in airway management. "The ABCs — airway, breathing and circulation — of CPR are now 'Da' ABCs of CPR," he said, with "D" standing for fibrillation and ventricular fibrillation "taking priority over all other resuscitation issues."
Delivering this form of therapy has been a prime goal of the American Heart Association (Dallas, Texas) for the past seven years, Durbin said, and has been driven by the availability of automated external defibrillator (AED) technology. He said that in the U.S., there are five manufacturers of AEDs: Cardiac Science (Irvine, California), Medical Research Laboratories (Buffalo Grove, Illinois), Medtronic Physio-Control (Redmond, Washington), Phillips Medical Systems (Seattle, Washington) and Zoll Medical (Burlington, Massachusetts).
AEDs were initially placed in airplanes and gambling casinos and are becoming increasingly available in workplaces, transportation systems and places of public assembly, Durbin said. Ironically, hospitals have been one of the slower adopters of this useful and life-saving technology. As AED usage increases in hospitals, he said he expects that "all care providers will be competent in AED use."
Durbin also said that "intubation has assumed a higher priority, and that the ET tube is now considered an important drug delivery port as well as for providing a secure airway." Since respiratory therapists in many hospitals are frequently called upon to manage and intubate patients in cardiac arrest, this has led to embracing the concept that they can play a role in drug delivery in other areas of medicine. One area that was mentioned was conscious sedation. In this area, respiratory therapists could use their existing knowledge of respiratory drug therapy along with their expertise in airway management and respiratory monitoring.
Charles Spearman, an associate professor in the department of cardiopulmonary sciences of the School of Allied Health Professions at Loma Linda University (Loma Linda, California), discussed critical care ventilators. He said that in the early 1980s, "mechanical ventilators were beginning to add a certain level of sophistication to ventilatory support that had not been readily available in ventilators of the 1960s and 1970s." Included were modes of support that allowed monitored, spontaneous breathing with practitioner adjustable support, electronically servo-controlled valves and options for pressure targeted modes. Monitoring systems, he said, were more integrated with ventilators and outputs for waveforms more readily available. Some systems offered options for modules of gas monitoring and mechanics calculators. Spearman noted that in the mid-1980s, microprocessor-controlled ventilators were introduced. Faster changes in fundamental processes such as ventilator modes and monitoring were made possible by programming (software) changes as well as more precise control over flow control valves and exhalation valves. The 1990s and early 2000s brought development of even more modes of ventilatory support, he said, including so called "dual modes" and those using "closed loop" systems.
"Newer modes of support are now focusing on controlling the patient's work of breathing," Spearman said, noting that "while there have been great changes in ventilator design over the last 20 years, direct links to patient outcomes are more difficult to find." He said lung protective strategies of limiting tidal volumes and end-inspiratory pressures can be provided by a variety of ventilator modes on current devices. However, he added that the best data to support lung protective ventilation was done with traditional (and relatively simple) assist-control, volume targeted ventilation.
Mechanical ventilator updates
Drager Medical (Telford, Pennsylvania) introduced the EvitaXL ventilator. The EvitaXL offers the benefits and features of the Evita 4 and Evita 2 Dura with some incremental innovative improvements. Along with a larger and more user-friendly screen, the EvitaXL ventilator possesses an online manual that supplies users with cause-and-remedy guidance for most clinical situations. Directly accessible settings are now easier and quicker to operate. A higher degree of configurability allows the clinician to choose precisely the features needed. The EvitaXL also offers a high degree of flexibility, since one unit can be used to ventilate infants through adults. Due to the modular system of Drager Medical ventilators, an Evita 4 can easily be upgraded to an EvitaXL. Soon, users of Evita 2 Duras also will be able to upgrade to an EvitaXL. This new model is an evolutionary addition that is as important strategically as clinically. The new model will allow Drager to offer an upgrade path for its users of the Evita 4 and the Evita 2 Dura. In addition, it will allow the company to offer several different models at various price points in the marketplace. Depending upon their new pricing, the company will have several different product offerings in the high price/high acuity features and mid-price/mid-acuity feature segments against Tyco Healthcare/Puritan Bennett (Pleasanton, California), Siemens Medical Solutions (Danvers, Massachusetts), Hamilton Medical (Reno, Nevada), Viasys Healthcare (Conshohocken, Pennsylvania) and Respironics (Pittsburgh, Pennsylvania). An overview of these segments is shown in Table 1.
Software updates expand product capability and usage. While not a new product, software improvements improve the functionality of existing products and expand their clinical capability. There were three notable software improvements introduced at the meeting, all involving enhancements to mechanical ventilator technology. Hamilton Medical introduced its Galileo Gold, which is pending 510(k) approval. This latest software improvement follows Hamilton's Blue, Silver and Classic versions. The Galileo Gold allows the clinician to perform noninvasive ventilation, bi-level pressure ventilation and to deliver a pressure-filled sigh breath with graphic analysis along with Smart Apnea BackUp, expanded Trending capability and Event Log. For existing users of the Hamilton Galileo ventilator, the ventilator platform will allow for the upgrade performance package to be installed on site. Tyco/Puritan Bennett introduced the Volume Ventilation Plus software option for its Model 840 ventilator. This option allows the clinician to deliver volume targeted, pressure breaths to all patients from neonate to adults. The option was necessary to allow Puritan Bennett to be more competitive to the other models in the high acuity features/ high price market segment (see Table 2).
Respironics showed its upcoming Auto-Track, which is pending 510(k) approval, and Respiratory Mechanics Software for its Esprit ventilator. This software 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 will also soon be available for users of the Respironics Esprit ventilator, also pending 510(k) approval. Auto-Trak accomplishes two clinical benefits — it provides leak compensation up to 60 liters per minute and optimal trigger sensitivity during routine mechanical ventilation and non-invasive use.
Pulse oximetry competition heats up
Tyco Healthcare/Nellcor (Pleasanton, California) showed its recently released next-generation N-595 pulse oximeter, called the Oximax. The device features a new pulse oximetry platform that is equipped with Nellcor's advanced digital signal processing technology. The unique chip in this device contains all of the sensor calibration information for the company's new line of sensors. One of the key features of the device is its ability to perform with substantial accuracy even when faced with patient motion and low perfusion simultaneously. This particular device also creates a communication link between the sensor and the monitor. The sensor message function provides troubleshooting tips for optional sensor application, and the sensor event report allows alarm event history to travel with the patient allowing for a quick assessment at different points of care.
The company also showed its Max-Fast Adhesive Forehead Sensor. The main benefit of the MaxFast forehead sensor is that it shows changes in SpO2 levels up to two minutes faster than digit sensors — giving clinicians an earlier warning of potential problems. This sensor can be used for up to two days with appropriate site inspections and changes. One of its key features is that it can be used on mechanically ventilated patients, since it can read through the ventilator artifact.
Masimo (Irvine, California) released its latest model Radical pulse oximeter, which features a new high-resolution blue screen that is easy to read from virtually every angle. The oximeter also features a new touchpad system that provides improved tactile feedback. Because the Radical pulse oximeter cradle can be detached from its docking station and used for patient ambulation and transport, Masimo also unveiled a new pouch for the clinician. And the company released a new line of L-shaped neonatal and infant sensors, representing the first release of its LNOP II series of sensors. These sensors feature an improved signal-to-noise ratio that is 30% better than the existing LNOT series
During the clinical sessions, Mitchell Goldstein, MD, led a group of clinicians from Pediatrix Medical Group and Queen of the Valley Medical Center (West Covina, California), in the presentation of a study investigating the process and outcomes during an evaluation of the Masimo Radical and Nellcor N-595 Oximax system. The Masimo SET unit was judged to be superior in both reliability and accuracy.
New products generate interest
Aerogen (Mountain View, California) showed the most interesting new product at the meeting. The Aeroneb Professional Nebulizer System, or Aeroneb Pro, is a multiple-patient-use device (steam sterilizable) that silently aerosolizes physician-prescribed solutions for inhalation without the need for a compressor or propellant. The device can be used with patients from infant through adult who require positive pressure breathing with a mechanical ventilator or those who use hand-held nebulizer therapy. The Aeroneb Pro system works inline with standard ventilator circuits and also independently with standard aerosol masks and mouthpieces.
The operational components of the Aeroneb Pro are the nebulizer unit, which incorporates Aerogen's aerosol generator, and the control module, which provides the requisite power for operation and determines the duration of treatment. The aerosol generator consists of a vibrational element and aperture plate with precisely formed holes. During operation, the control module drives the vibrational element at a frequency of over 1020 kHz to create a micro-pumping action that draws solutions in contact with the concave surface of the aperture plate and through the openings to produce a fine droplet, low velocity aerosol. The resulting aerosol is tailored to optimize lung deposition with its small particle size.
Fisher & Paykel Healthcare (Laguna Hills, California) unveiled an oral CPAP interface called the Oracle, which is for anyone who can't tolerate a nasal mask and can be used with any CPAP or bi-level device.
Instrumentation Laboratories (IL; Lexington, Massachusetts) introduced IQM to its GEM Premier 3000 critical care analyzer. The GEM 3000 is a blood gas, electrolyte, glucose, lactate and hematocrit analyzer. IQM is an automated quality assurance system that replaces the use of conventional external quality control. Traditional quality control methods for clinical diagnostic equipment require running manually several control products daily. These are typically run at eight-hour intervals and require significant manual involvement by a clinician, in addition to protocol oversight and documentation. IQM is an active quality control program that helps to ensure that the GEM Premier 3000 analyzer is providing accurate results, IL said. IQM continuously monitors operation of the entire analytical process, including sensors, fluidics and electronics. It follows the same path as the sample follows so no part of the system is left unchecked. Additionally, IQM automatically performs and documents corrective actions upon detection of any error. All manual processes associated with traditional quality control are eliminated, according to IL.
Portex (Keene, New Hampshire), a part of Smiths Group plc, displayed two products. The first was a Blood Gas Syringe with Needle Safety. Even though this product has been on the market for 10 years, with the recent Needlestick Safety Act and Bloodborne Pathogens Directive, this type of needle protection product is garnering new interest and demand. The device protects clinicians from accidental needlesticks. Portex also introduced a cricothyrotomy device called Nu-Trake. This device comes in an easy-to-use kit. To perform a cricothyrotomy, the clinician attaches the sharp device to the cannula and makes an initial puncture into the cricoid membrane. The clinician then removes the sharp and places a 4.5 mm dilator into the cannula. This expands the opening to create an artificial airway. At this point, an airway is established and the patient can be bagged with a manual resuscitator. After one minute of bagging the clinician removes the 4.5 mm dilator and inserts a 6.0 mm dilator and returns to bagging the patient. It is necessary to do this in steps to prevent swelling of the cricoid membrane, the company said.
Medex (Dublin, Ohio), an employee-owned company with manufacturing operations in the U.S. and Europe, acquired the business of IPI Medical in May. Medex offers a comprehensive array of fluid and drug delivery, diagnostic and interventional imaging, pressure monitoring, and now cardio-pulmonary products. Through a newly created division, Medex Cardio-Pulmonary, two new products were launched at this year's AARC gathering. The first is a humidification chamber and feed system for use with high frequency oscillatory ventilators and nasal CPAP. The technology delivers optimal humidity by bringing together an innovatively designed humidification chamber and feedset. Also launched was an existing technology for managing endotracheal tube cuff pressure. The PressureEasy is designed to give the respiratory therapist the ability to constantly monitor the endotracheal tube cuff pressure at nominal pressures to prevent ventilator associated pneumonia, inadvertent extubations and subglottic tissue necrosis.
Nellcor showed as an investigational device its upcoming N-80 Capno Probe Sublingual System. It will be the first device to measure sublingual carbon dioxide. Beta testing and clinical research programs are currently under way. The company said it expects to release the product early next year.
Viasys Healthcare (Conshohocken, Pennsylvania) introduced the Hi-Ox80 disposable oxygen mask. The device delivers greater than 80% oxygen at 8 liters per minute for patients that require high oxygen concentrations or high liter flows. Brief treatment with high oxygen concentrations at greater than 80% has been recently reported to have important benefits for patients undergoing surgical procedures. Viasys said a recent study of patients requiring colon-rectal surgery reported that patients given 80% oxygen during their operation and for two hours postoperative had a 50% reduction in postoperative infections. A second study reported a 43% reduction in postoperative nausea and vomiting in patients who received more than 80% oxygen as compared to patients who only received the typically delivered 30% oxygen. Viasys also showed its Orion Nasal CPAP System. Introduced in July, the device is designed for the treatment of sleep apnea and will compete in the CPAP device market against the Respironics Solo Plus LX CPAP System, ResMed (Poway, California) S6T Elite and S7T Elite and Tyco/Puritan Bennett Goodnight 418 models.