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The U.S ventilation industry is being propelled in many directions by forces that are growing in complexity and urgency.
Aging baby boomers, technological advancements, mass casualty scenarios, and cost containment are creating an increased need for equipment to manage patients requiring some form of mechanical ventilation.
Over time, our techniques and equipment for assisting breathing have evolved from little more than a reed inserted into the trachea in the 16th century to a $900 million domestic industry in the 21st century.1
Thousands of patients, from premature infants to the elderly, depend on mechanical ventilation when they are experiencing respiratory failure from acute or chronic illness, trauma, and post-surgical care. The mean length of ventilation is 5.9 days, and the mean incremental cost of mechanical ventilation in intensive care unit patients is $1,522 per day.2,3
Competition and innovation
The mechanical ventilation industry is growing 4.5 percent each year.1 Driving this growth is the current aging fleet of ventilators already in operation, the rapidly increasing proportion of citizens older than 65, and developing needs such as flu pandemic and disaster preparedness.
There currently are approximately 28 manufacturers of mechanical ventilators and supplies operating within the U.S. These companies offer a wide array of equipment ranging from unsophisticated ventilators intended for use in the mass casualty sector to high-end ventilators intended for use in the state-of-the-art intensive care suite.
Current generations of mechanical ventilators are software-based instruments which allow customers to pick configurations that most benefit their particular institution. This process makes the new technology more affordable and can extend the length of time a particular ventilator can be in operation. It has become more common, for instance, for critical care ventilators to provide noninvasive positive pressure ventilation with leak compensation.
The process of software development for mechanical ventilation proves a big advantage for manufacturers and customers. After the original sale of equipment, the manufacturer will continue to market new modes and applications. Consumers can take advantage of the new software packages without the cost of a new ventilator.
Focus on lung protective strategies
Cost containment is a particularly important topic for all health care sectors. When ventilation is implemented improperly, iatrogenic lung injury can occur, increasing mortality and, in most cases, cost of care.
The National Institutes of Health published a study in the New England Journal of Medicine showing a significant improvement in survival of patients who were ventilated with lower Vt (6 mL/kg) when compared to patients ventilated with higher Vt (12mL/kg). This study came on the heels of research demonstrating improved mortality by the use of a low tidal volume and positive end-expiratory pressure.4,5
Investigators do not understand fully the exact cause for the decreased mortality. And while the results of the NIH study continue to be debated, physicians widely accept the premise that mechanical ventilation can impact morbidity and mortality. These studies and others have increased the awareness of lung protective strategies in patients with acute respiratory distress syndrome or acute lung injury.
Patients suffering from ARDS or ALI typically are the most difficult patients to manage and often succumb to multi-system organ failure. Their mortality rates vary according to sources but can be as high as 60 percent in patients older than age 65 and as low as 30 percent in the young. The cost for care of these patients can reach $100,000 per incident.6 The mechanical ventilation field is emphasizing better care and outcomes.
Through safety initiatives or cost-containment processes, the industry is attempting to combine evidence-based research and industry forces to create a profitable and effective patient-focused market.
Implementing the ventilator bundle
One of the most popular trends in mechanical ventilation is the advent of the ventilator bundle to prevent ventilator-associated pneumonia. A bundle is a collection of processes needed to effectively and safely care for patients undergoing particular treatments with inherent risks. It is a grouping of several scientifically grounded elements essential to improving clinical outcomes.7 The ventilator bundle elements are as follows:
head of bed elevation 30° to 45°
daily sedation vacation
assessment for readiness to extubate
deep vein thrombosis prophylaxis
stress ulcer prophylaxis
frequent oral care.
Each intervention is important to the patient's outcome, but many can be overlooked in our busy health care environment. Bundles address this problem by giving the bedside caregiver the evidence-based tools they need to provide safe, effective care.
The ventilator bundle has been effective at preventing VAP in patients on mechanical ventilatory support by endotracheal tube or tracheostomy for 48 hours or longer. VAP is an expensive nosocomial event, with costs ranging from $5,000 to $26,000.8 In addition to the increased costs, VAP increases mortality and ICU length of stay.
Disaster preparedness
Emphasis by local, state, and national governments on the availability and distribution of mechanical ventilators for disaster preparedness also is shaping the dynamics of the mechanical ventilation industry.
The U.S. Centers for Disease Control and Prevention's Strategic National Stockpile program maintains 6,000 mechanical ventilators for distribution to states in case of a mass casualty event. Fearing that supply will be inadequate, states have begun to purchase and stockpile their own ventilators.
The American Association for Respiratory Care issued guidelines for the acquisition of ventilators for use during crisis scenarios. They recommend emergency ventilators must be easy to use, require minimal maintenance, and include batteries that allow them to operate for four to six hours when electric and gas supplies are unavailable.
The ventilators must be able to operate across a wide range of patient populations and control tidal volume, respiratory rate, inspired oxygen concentration, and positive end-expiratory pressure. Continued research and development of unique and affordable modalities for disaster response is needed.
However, purchasing ventilators for disaster response is only a part of the equation. Respiratory care managers must not only help to assess their institutions' ventilator capacity, they also ust find ways to train enough people to assist respiratory therapists and physicians in administering mechanical ventilation if a mass casualty event were to occur.
Collaboration among ventilator manufacturers, government at all levels, and end users is essential to disaster preparedness.
A future of automation
The introduction of microprocessor technology into ventilators has led to many advancements.9 This accelerated evolution has enabled manufacturers to create complex algorithms that auto-adjust ventilator parameters based on measurements and calculations, thus improving patient-ventilator synchrony.
Other recent innovations have allowed clinicians to program the ventilator with institutionally specific weaning algorithms. This automation could develop into a new wave of customization and possibly improved adherence to standard protocols.
A new generation of modes measures patient parameters and automatically adjusts ventilatory support to achieve a predetermined threshold of patient work of breathing. These modes can create scenarios in which patients are supported sufficiently to relieve the excessive work of breathing but sensitive enough to auto-titrate support as needed. Proportional assist ventilation is becoming more available and continues to gain in popularity.
The most recent advancement in mechanical ventilation is the development of neurally adjusted ventilatory assist (NAVA), which couples the electrical activity of the diaphragm to the ventilator trigger and patient flow demand.
This innovation could impact patient-ventilator asynchrony caused by flow and pressure triggers. In the future, this may be a standard means of breath initiation for many patient populations.
As the mechanical ventilation industry grapples over the next decade with multiple impending challenges, the partnership between industry, academia, practicing clinicians, payers, and patients will be invaluable.
For a list of references, look under the "Magazine" tab at www.advanceweb.com /respmanager.
Paul Luehrs RRT, BSRT, BSEd, is adult critical care coordinator for respiratory care at CoxHealth in Springfield, Mo.
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