After successful 510(k) clearance, Hamilton Medical has released the new active humidifier Hamilton-H900 in the US. The device features improved ergonomics, ease of use, and facilitated handling, the company says.

The product release is a part of Hamilton’s focus on expanding its “Intelligent Ventilation” concepts to devices directly involved in critical care ventilation.

“Humidification is an important part of respiratory care. When we developed the Hamilton-H900 humidifier, we talked to many clinicians to understand what they would improve in conventional humidification,” said Jens Hallek, president of Hamilton Medical.

Easier handling of circuits, cables and connections, an improved user interface, reduction of rain-out, and increased safety were the most requested enhancements. The Hamilton-H900 aims at improving humidification in exactly these areas.

Handling

The Hamilton-H900 comprises only two components, which are delivered preassembled and ready to use: The wall-heated breathing set including the new all-in-one connectors, integrated temperature probe, water refill tube, Y-piece, and water chamber, and the humidifier base with the user interface and the heating plate.

This saves time, increases efficiency, and facilitates the handling of the humidifier, as well as reducing the risk of contamination. With no need to worry about extra cables to connect or disconnect anymore, the caregiver only needs to slide the water chamber into the humidifier and connect the breathing circuit to the patient.

Rain-out and temperature control

The breathing circuits for the Hamilton-H900 integrate the heater wires into the circuit wall. This eliminates the cold interface between heated breathing gas and ambient temperatures, and leads to significantly reduced condensation and rain-out effects in the breathing circuit.

To perfectly adapt the humidification therapy to the individual patient and environmental conditions, the Hamilton-H900 humidifier allows for manual adjustment of the chamber temperature and temperature gradient. Having too much condensation in the tubing can, therefore, be avoided by adjusting the temperature gradient.

By reducing the need to open the circuit to drain condensate, the Hamilton-H900 minimizes the potential for the spread of pathogens associated with the development of ventilator-associated pneumonia (VAP).

Ergonomic and intuitive user interface

Due to the ergonomic design, the user interface can be easily seen and operated from a standing position, and provides all the information the caregiver needs at a glance. The large, high-contrast LC display provides excellent readability, even in direct sunlight.

Alarms are displayed with self-explanatory icons on the LC display, and can be heard and seen from afar thanks to the bright alarm lamps and audible alarm.

More information is available on the Hamilton Medical website.

Ventilator-associated lung injury (VALI), an acute lung injury that can develop during mechanical ventilation, increases complications and mortality risk in the intensive care unit.

By Phyllis Hanlon

Since 1994 when the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), established the ARDS Network “to efficiently test promising agents, devices, or management strategies to improve the care of patients with ARDS (acute respiratory distress syndrome),” many, but not all, hospitals have complied with the recommendations.¹ In fact, during the last 22 years, a number of other strategies have been attempted to achieve appropriate ventilation without the risk of ventilator-associated/induced lung injury (VALI/VILI).

Synchrony

Even though 6cc/kg patient body weight of tidal volume has become the “ideal,” Robert Duncan Hite, MD, chairman, Critical Care Medicine at Cleveland Clinic, questions its validity. “There is evidence it may be too big. Admittedly, 6 cc is much safer than 12,” he said. “Over 24 hours the patient occasionally asks the machine to take a bigger breath. During the course of a day if it’s 7.2, is that unsafe? We don’t know.”

Hite pointed out that current techniques and tools employ a “straightforward approach,” ie, they reduce the amount of volume to reduce the risk of injury. “But synchrony between the patient and the ventilator is the biggest single challenge. On a breath-by-breath basis the patient is interacting with the device. There is a need to constantly balance,” he said. “You can’t control every breath. The technology on the vent allows you to do that, but it might not be consistent with the patient’s needs.”

Furthermore, current practices focus on the moment the respiratory therapist and physician are standing at the bedside looking at the ventilator, according to Hite. “That’s important, but I think the next level is to develop the capability of capturing what’s happening when they are not there. The more we can utilize the ability to summarize information from the patient during the day or during a specific time, the better the outcome will be,” he said. “We can use the trending data to see the range of volume, the frequency of distribution over six to 24 hours, an element of utilization of the device that could give us a better advantage.”

Experience and training is key to understanding the nuances of the ventilator as it performs its functions, according to Hite. “There is patient-to-patient variation. In fact, within one patient there might be variation during the day or over the course of hours. To understand all the nuances of what the software is supposed to do takes a lot of experience. We know that giving too big a volume is a reasonably predictable way to cause injury,” he said, adding that understanding other variables, such as the size of the breath and the amount of change in pressure, will help predict a good outcome.

Personalized Approach 

Edwin Coombs, MA, RRT-NPS, ACCS, FAARC, Dräger, noted that positive end expiratory pressure (PEEP) is currently the ventilator parameter that is most often personalized to the individual patient’s lung pathology and used to keep the lung open and stable. “Personalized PEEP can be set using a variety of techniques most of which require a lung recruitment maneuver,” he said. “However, when using APRV (airway pressure release ventilation), the lung is kept open and stable by setting a very short expiratory duration to maintain both a level of PEEP but, more important, to be shorter than the collapse time constant of the alveolus.”

Two studies,^2-3 one from 2005 and a more recent one from 2016, cite the importance of “measuring the change in the slope of the expiratory flow curve, which becomes steeper with increasing lung injury. Coombs explained that Dräger’s unique feature, known as “Auto-Release,” tracks the patient’s lung dynamics and adjusts the Tlow setting to maintain the desired peak expiratory flow rate (PEFR).

Creating appropriate ventilator protocols requires collaboration, said Coombs. “When developing a mechanical ventilation protocol to reduce or prevent VALI/VILI, an inter-disciplinary group of physicians, respiratory therapists and critical care nurses should be created to examine the current standards of care, controversies or questions surrounding studies, promising new approaches, and the like. The goal of avoiding alveolar distention and alveolar shear-stress should be kept in mind,” he said.

“Regardless of the specific protective approach selected, the protocol should be applied consistently with well-trained clinicians operating the ventilator. One consideration of executing a protocol using Dräger ventilator technology is to base initial parameter settings based on ideal body weight, which can support standardization when initiating mechanical ventilation support.”

Making Adjustments

Today’s ventilators are more sophisticated and can carefully titrate gases based on the patient’s desire. Newer models blend three variables: flow, pressure and volume. Hite explained that these devices can adapt to patient need and are better able to provide flow and control volume and pressure concurrently on a continuous basis. “If all patients were on a device with sophisticated ability to titrate the three variables, it would make a difference in a patient’s comfort and the outcome,” he said.

Even with enhanced features, ventilator settings still need to be adjusted at times. When making adjustments, clinicians should consider how these changes will impact the microenvironment (ie alveoli and alveolar ducts), Coombs pointed out. “Thus, a major challenge is better understanding of how mechanical ventilator settings impact alveolar microstrain, where strain is the change in alveolar size in response to a given stress; in the case of mechanical ventilation the stress is the size of the tidal volume,” Coombs said.

A 2014 study⁴ examined which components of the mechanical breath caused the most and the least alveolar microstrain and found that APRV, with a prolonged inspiratory phase and a brief expiratory release phase, was optimal at reducing strain at the alveolar level.

Another study⁵ has shown that reducing whole lung dynamic strain by reducing tidal volume and increasing PEEP could prevent ARDS in a large animal model. “Combined, these studies suggest that if the mechanical breath can be delivered to induce minimal dynamic strain that the lung will be protected,” said Coombs.

Additionally, the clinician should consider the potential impact of the mechanical breath at causing both “volutrauma” and “atelectrauma.” Coombs said, “Understanding these two VILI mechanisms, and using a ventilator strategy that creates a homogeneously ventilated lung will minimize the risk of VALI/VILI, which would exacerbate ARDS incidence, morbidity and mortality.” The 2013 study⁵ found that the normal homogeneous lung can tolerate higher plateau pressures (ie: 40 cm H₂O) when not exposed to cyclic collapse during exhalation.

Device Manufacturers’ Role

Once a hospital purchases a mechanical ventilator, or any other medical device, the manufacturer generally provides in-service education for their devices, which might include hands-on training as well as didactic training to raise the level of understanding in how their respective devices operate, according to Coombs. “To reduce variability in a lung protective approach, the importance of establishing a protocol cannot be understated, and requires the facility to have a multi-disciplinary team working together,” he said. “Understanding not only training opportunities but how an integrated approach to providing overarching solutions in the ICU, NICU, and OR to improve workflow, safety, efficiency and cost-effectiveness are key when having discussions with vendors/manufacturers.”

In addition to routine device in-services, Dräger provides a number of value added education services for its customers and respiratory therapists.

“Our ‘Breath Ahead’ education and networking portal provides the RT marketplace the opportunity to discuss topics with key leaders in the field as well as receive complimentary education credits. Dräger customers have access to our partner, Intensive Care Online (ICON) where monthly webinars, online training, 24×7 live phone support and other supportive/educational opportunities are provided. The interdisciplinary staff at ICON includes physicians, nurses, respiratory therapists and pharmacists who can help transfer the advancements in treatment enabled by modern ventilators into improved outcomes for customers,” Coombs said.

“Throughout the year, Dräger offers regional conferences and often supports high-fidelity lab training. Additionally, as a corporate partner of the AARC, Dräger sponsors various education programs and key initiatives for its members.”

ARDSNet Follow Up

The greater Colorado academic system, which includes the University of Colorado, Denver Health and Jewish National Health, participated in ARDSNet, according to Kenneth E. Lyn-Kew, MD, section head, Critical Care Medicine, assistant professor in the Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine at National Jewish Health in Denver.

Lyn-Kew reported that National Jewish is now participating in a follow up project. PETAL (Prevention and Early Treatment of Acute Lung Injury) builds on the goals, strengths and accomplishments of ARDSNet and is also exploring new therapies. “Twelve clinical centers and one clinical coordinating center, funded by the NHLBI, will test new treatments or approaches to improve clinical outcomes,” said Lyn-Kew. “PETAL forces the ICU to continue to ensure it’s delivering state-of-the-art care for the patient. The hallmark is low tidal volume ventilation. The PETAL Network will continue to look at ways to minimize and prevent ARDS.”

Moving forward, Lyn-Kew foresees additional studies regarding lung protection strategies. “We learned from the ARDSNet after 20 years of research that other than turning down the pressure and volume in the ventilator there has been an arm’s length of other things to protect the lung that haven’t worked, such as steroids, high levels of PEEP, multiple drug studies,” he said. “There will be continued collaborative multi-center trials looking for additional technology and therapies.”

Until a consensus can be developed, which requires further study, a clinician should utilize evidence-based medicine to guide decision-making, according to Coombs. “The bedside clinician should have a full understanding of the ventilator being used, its advantages and its limitations. The approach to mechanical ventilation should be interdisciplinary and protective in nature to avoid VILI/ARDS, which should include early goal-directed therapy for patients identified as ‘at risk’ or susceptible to VILI,” he said. “This should address low tidal volume, moderate to high PEEP levels, and opportunity to evaluate dynamic pulmonary mechanics to consider APRV with a personalized mechanical breath profile.” RT

Phyllis Hanlon is a contributing writer to RT. For further information, contact RTmagazine@nullallied360.com

References

1. Villar, J. Sulemanji, D. Kacmarek, RM. “The acute respiratory distress syndrome: incidence and mortality, has it changed?” Current Opinion Critical Care, 2014; 20(1)3-9.

2. Habashi, N. “Other approaches to open-lung ventilation: Airway pressure release ventilation.” Critical Care Medicine, March 2005, 33 (3), S228-S240.

3. Sumeet V. Jain, Michaela Kollisch-Singule, et al. “The 30-year evolution of airway pressure release ventilation (APRV),” Intensive Care Medicine, 2016, 4:11, 1-18.

4. Michaela Kollisch-Singule, MD, Bryanna Emr, et al. “Airway Pressure Release Ventilation Reduces Conducting Airway Micro-Strain in Lung Injury.” Journal of American College of Surgery, 2014, 09.011, 968-974.

5. Alessandro Protti, MD1; Davide T. et al. “Lung Stress and Strain during Mechanical Ventilation: Any Difference between Statics and Dynamics?” Critical Care Medicine, April 2013, 41:4, 1046-1055.

Hamilton Medical has received 510(k) clearance for a Neonatal option on its Hamilton-MR1 ventilator, which will allow ventilation therapy during MRI procedures for infants and newborns.

With the new Neonatal option for the Hamilton-MR1 ventilator, neonatal patients can be transported from the ICU to the MRI suite and back without having to change anything about the ventilation. These seamless transfers reduce the risk of de-recruitment or other setbacks, which may result in a longer hospital stay and more discomfort for your most fragile patients, according to Hamilton Medical.

The Neonatal option optimizes the Hamilton-MR1 for MR-Conditional neonatal ventilation. With tidal volumes as low as 2 ml, the device is designed for safe, effective, and lung-protective ventilation for neonates, the company said via press release. The intelligent leak compensation function IntelliTrig automatically adjusts the inspiratory and expiratory trigger sensitivity to potential leaks. This ensures adaptive synchronization with the neonate’s breathing pattern.

The compact and robust housing, an integrated high-performance turbine, and powerful internal batteries make the device well-equipped for patient transport and easy to handle for the caregiver. The wide range of modern and classic ventilation modes allows you to offer all your patients, from neonates to adults, the same high level of ventilation care as at the bedside, whether before, during, or after the MRI procedure.

The Hamilton-MR1 is the first ventilator able to be used at a magnetic field strength of 50 mT, equivalent to 1 m distance for a 3T static magnetic field scanner, without creating any MR image artifacts. Positioning a medical device too close to the MRI scanner can have fatal consequences. For maximum safety, the Hamilton-MR1 continuously monitors the magnetic field with TeslaSpy, an integrated gaussmeter, and gives you an audible and visual signal if you are getting too close.

Hans Rudolph Inc has released its new Eagle Disposable Masks for noninvasive ventilation (NIV) and administration of oxygen and other breathing gases.

The new disposable interface concept allows one mask to stay with patient from emergency accident site EMS to transport vent, emergency room vent, acute care, surgery, sub-acute care, to hospital room respiratory support NIV procedures.

Features include:

• 3 color-coded sizes (S, M, L)
• Chin cup
• Low dead space, lightweight
• Built-in 22mm ID (female) port
• Clear view
• Simple headgear
• Integrated ports for scope and gases
• 4 optional swivels for connection to respiratory devices

More information is available on the Hans Rudolph website.

Dräger donated 11 Savina 300 and eight Evita Infinity V500 ventilators to respiratory therapy schools at this year’s AARC International Congress. By providing the latest mechanical ventilation technology, Dräger is helping to foster a greater learning experience for RT students — professionals critical to the future of healthcare.

RT schools are on the frontlines of training the next-generation of respiratory professionals – a role that will become even more important as the healthcare industry prepares for the demands of an aging population. The donation of Dräger ventilators gives RT students the invaluable experience of training with modern-day equipment in a simulated lab setting.

“Finding funding for capital budgets in educational programs can be exceptionally difficult, and many students are benefiting from the equipment donated by Dräger,” said Shawna Strickland, PhD, RRT-NPS, RRT-ACCS, AE-C, FAARC and Associate Executive Director-Education at AARC. “We appreciate the extra efforts of Dräger to improve respiratory care education and maximize positive patient outcomes.”

The RT schools that received the donations, include:

• Antelope Valley College
• Bellarmine University
• Catawba Valley Community College
• Concorde Career College
• Elizabethtown Community & Technical College
• Florida SouthWestern State College
• Georgia State University
• Hillsborough Community College
• Kettering College
• Lake Superior College
• Nebraska Methodist College
• Spartanburg Community College
• SUNY Stony Brook
• SUNY Upstate Medical Center
• Tacoma Community College
• Trident Technical College
• UTMB-Galveston
• Weber State University
• Youngstown State University

“Dräger has donated 36 ventilators and counting to US schools as part of AARC’s education initiatives,” said Ed Coombs, MA, RRT-NPS, ACCS, FAARC, Director of Marketing for Intensive Care, Dräger Inc. “We pride ourselves on being at the forefront of RT education initiatives, and supporting academia’s efforts to ensure future professionals are an integral part of tomorrow’s healthcare community.”

ResMed’s new AirFit F20 full face mask and N20 nasal mask are now available in the United States.

The AirFit 20 series introduces a new InfinitySeal silicone cushion that adapts to the unique facial contours of each patient and is designed to provide a universal fit for all patients, regardless of face shape or size. Plus, both masks feature magnetic clips for easy fit and removal.

Tested to perform at high therapy pressures, the AirFit F20 full face mask provided an effective seal for more than 97% of patients, while the AirFit N20 nasal mask sealed on more than 99%.

More information is available on ResMed’s website.

Hamilton Medical has released the new Hamilton-C1 neo, which combines a range of therapy options with mobility into a ventilator designed specifically for neonates. Combining invasive and noninvasive modes with the options of nCPAP in a very small footprint, this dedicated neonatal ventilator makes it easier for caregivers to help the most fragile of patients, according to the company.

2017 is here, but before we turn the page on the new year, RT is taking a look back at our top articles published in 2016. The following is a list of the 10 most-read articles on RTmagazine.com from January 1st through December 31st, 2016. (To be included in the list the article must have been published in 2016.) Click on the headlines to read the articles.

Happy New Year to all and thank you for your continued support of RT!

Gaumard Scientific Co has released its most advanced neonatal patient simulation manikin, the Super Tory. The new manikin’s computer-controlled dynamically-compliant lungs are so realistic that they  accurately respond to real mechanical ventilation, Gaumard says. Super Tory was unveiled on January 29 at the 2017 International Meeting on Simulation in Healthcare in Orlando.

“At the touch of a button, Super Tory’s respiratory system goes into acute distress and his entire body reacts. He cries, frowns and grows pale. There’s no mistaking that Super Tory is very sick – and that every member of the respiratory care team will need to work together to revive him,” according to a Gaumard press release.

“Every specialist gets to participate in Super Tory’s treatment,” says John Eggert, executive vice president of Gaumard Scientific Co. “Super Tory suspends disbelief with anatomical and physiological accuracy never before seen in neonatal simulation. It’s the first neonatal simulator to offer heart and lung interaction as well as motion in a mobile platform.”

Respiratory therapists, for example, can stabilize Super Tory with ACV, SIMV, CPAP, PCV, PSV or NIPPV, using real equipment in the NICU.

“You assess Super Tory for early onset sepsis, hyperbilirubinemia, pneumonia with pneumothorax and other conditions using real vital signs monitors. You can accurately check his ECG-derived respiration rate, pre- and post-ductal SpO₂, oscillometric NIBP and pacing and defibrillation.  You can observe his pain as his facial expressions change and you can track his chest wall motion and programmable arm and leg movements.”

Super Tory is wireless and tetherless to ensure continuity of care as he is moved from the labor and delivery room to the NICU, Gaumard says. Super Tory can be treated anytime, anywhere and remains fully functional in transit due to an internal, rechargeable battery that provides up to eight hours of wireless, tetherless operation — an unprecedented technological feat in a simulator that’s just eight pounds and 21 inches.

More information is available on the Gaumard website.

Hans Rudolph Inc has released its new Eagle Disposable Masks for noninvasive ventilation (NIV) and administration of oxygen and other breathing gases.

The new disposable interface concept allows one mask to stay with patient from emergency accident site EMS to transport vent, emergency room vent, acute care, surgery, sub-acute care, to hospital room respiratory support NIV procedures.

Features include:

• 3 color-coded sizes (S, M, L)
• Chin cup
• Low dead space, lightweight
• Built-in 22mm ID (female) port
• Clear view
• Simple headgear
• Integrated ports for scope and gases
• 4 optional swivels for connection to respiratory devices

More information is available on the Hans Rudolph website.

Royal Philips has launched its DreamStation Advanced Therapies platform, including BiPAP autoSV and AVAPS devices, to support patients suffering with sleep-disordered breathing and respiratory insufficiencies.

Built on sophisticated, clinically-proven algorithms, BiPAP autoSV aims to deliver optimal ventilation with minimal intervention so patients experience comfortable, restful sleep, Philips said in a press release. Meanwhile BiPAP AVAPS is designed to deliver effective and comfortable ventilation therapy so patients can experience an improved quality of life.

Worldwide, more than 100 million people have obstructive sleep apnea and a significant percentage suffer from more complex sleep-disordered breathing, Philips said. Furthermore, an estimated 65 million suffering from COPD, and even more suffering from specific respiratory insufficiencies due to other chronic or neuromuscular diseases, all requiring unique therapy.

To address the varying needs of these complex disorders, Philips designed the DreamStation Advanced Therapies BiPAP autoSV and AVAPS devices, the company said.

“Treating patients with complex breathing disorders is not always straightforward, and every patient has unique therapy needs that can change night to night,” said Mark D’Angelo, Sleep Therapy Business Leader, Philips Sleep & Respiratory Care. “In addition to medical support, they require guidance and encouragement. With these updates to our Dream Family, we can provide individualized support for a wider range patients and empower clinicians to deliver the most efficient and best care possible.”

The DreamStation Advanced Therapies are fully-integrated through Philips Encore Anywhere patient management tool. This connectivity provides automated support for the patient’s specific and changing needs as well as remote monitoring capabilities support for physicians, durable medical equipment (DME) providers and caretakers to intervene when needed to minimalize adverse events.

Currently available in in select markets including France, Australia and the United States, the devices are expected to become available globally by the end of 2017.

RT Magazine’s product comparison matrix for NIV, PAP, and Oxygen Therapy is now available as a downloadable pdf.

Click here to download.

…

AirLife® NIV mask

According to research published in the journal Medicine, for patients with acute COPD exacerbations and hypercapnic encephalopathy, noninvasive positive-pressure ventilation (NPPV) combined with a noninvasive strategy to clear secretions during the first two hours may be more beneficial than conventional mechanical ventilation (CMV).

A total of 74 patients received NPPV, and 90 patients received CMV. Inclusion criteria included physician-diagnosed acute exacerbations of COPD, spontaneous airway clearance of excessive secretions, arterial blood gas analysis requiring intensive care, moderate-to-severe dyspnea, and a Kelly-Matthay Scale score of 3 to 5.

According to the researchers, arterial blood gases and sensorium levels improved significantly within 2 hours among patients in the NPPV group, with lower hospital mortality, fewer complications and invasive devices per patient, and superior weaning off of mechanical ventilation. Mechanical ventilation duration, hospital stay, and 1-year mortality were similar between the 2 groups.

“The use of an oropharyngeal airway and suction aspiration, in combination with appropriate positioning of the patient and nebulized inhalation of salbutamol/ambroxol, was a feasible, simple, safe, and effective method for clearing respiratory secretions during the first 2 hours of NPPV in patients in the ICU with acute exacerbations of COPD and hypercapnic encephalopathy,” stated the study authors.

Read more at www.clinicaladvisor.com

Dräger’s portfolio of medical ventilators has received the Frost & Sullivan 2017 Medical Ventilation Product Leadership Award, according to a press announcement from the company.

Dräger’s ventilators were recognized for their reliability and quality, stellar support services and robust, flexible design, fitting the needs of a broad range of care settings and patient types, the company said.

Frost & Sullivan acknowledged Dräger’s Babylog VN500 ventilators that fill the critical need for neonatal- and pediatric-specific ventilators in North America. Additionally, the ventilators were recognized for their easy transfer, storage and analysis of data. Dräger was lauded for its 24/7/365 intensive care online (ICON) support services.

For the award, Frost & Sullivan analysts evaluated:

• Product Family Attributes (match to need, reliability/quality, product/service value, positioning and design) and
• Business Impact (financial performance, customer acquisition, operational efficiency, growth potential and human capital).

Dräger received a 9.0 score (on a 10-point scale), a full point higher than the nearest competitor.

“During the judging process, we heard from Dräger customers who noted the company’s commitment to mechanical ventilation enhancements and its role as a partner in care,” said John Weber at Frost & Sullivan. “Dräger is the leader in the North American ventilator market, addressing the most pressing needs of critical care, transport care and neonates.”

“We are thrilled to receive this prestigious award, as it speaks to Dräger’s long-time commitment to innovating the mechanical ventilation market,” said Lothar Thielen, president and regional CEO North America, Dräger. “We will continue to work closely with the healthcare community to ensure our ventilators continue to be the gold standard for care. Thank you to Frost & Sullivan for this honor.”

More information is available on Dräger’s website.

A new $100,000 two-year research fellowship in the area of noninvasive ventilation (NIV) in COPD has been launched by the American Thoracic Society Foundation, thanks to a grant from ResMed.

The “ATS Foundation/ResMed Research Fellowship in Noninvasive Ventilation in COPD” award is funded by ResMed.

“This award comes at a time of high demand for increasingly effective treatments of COPD, which affects 65 million people worldwide and is the third leading cause of death in the world, behind only heart disease and stroke,” said Dean Schraufnagel, MD, chair of the ATS Foundation and a faculty member at the University of Illinois at Chicago. “We’re grateful to ResMed for supporting this research, and look forward to it helping improve countless lives in the future.”

Recent studies have already begun to establish the clinical benefits of NIV for COPD, including:

• Lowering six-month hospital readmission rates by 47 percent.¹
• Reducing the risk of death over one year by 76 percent.²

“Through this award, the field of respiratory medicine stands to gain more valuable knowledge about the use of NIV for the treatment of COPD with the ultimate goal of improving the lives of patients and the efficiency of our health care system as a whole,” said Carlos Nunez, MD, ResMed Chief Medical Officer.

More information is available at the ATS Foundation website.

References

1. Galli JA, et al., Home non-invasive ventilation use following acute hypercapnic respiratory failure in COPD, Respiratory Medicine 2014 http://dx.doi.org/10.1016/j.rmed.2014.03.006.
2. Köhnlein T et al. Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease – A prospective, multicentre, randomized, controlled clinical trial. Lancet Respiratory Medicine 2014;2:698–705.

Ventec Life Systems has received 510(k) clearance from the US FDA for VOCSN (pronounced VOX-SEN), a portable life support device that combines five respiratory therapies: Ventilation, Oxygen, Cough, Suction, and Nebulization.

VOCSN works across the continuum of care, from the hospital to home, and for pediatric patients weighing more than 5 kg to adults.  VOCSN is designed to improve care for patients with neuromuscular disease (eg muscular dystrophies, ALS), impaired lung function (COPD, cystic fibrosis, lung cancers, emphysema), spinal cord injury, and pediatric development complication (eg premature births, chronic lung disease). Patients can get all five therapies or just the mix of therapies needed.

According to Ventec Life Systems, VOCSN is more than 70% lighter and smaller than existing machines, features a nine-hour on-board battery, and is controlled through an intuitive touchscreen interface and user-friendly operating system.

VOCSN includes:

• A portable critical care ventilator that provides invasive, noninvasive, and mouthpiece ventilation.
• A portable oxygen concentrator that delivers the equivalent of 6 L/min of oxygen, plus it can be fitted with external oxygen sources and includes an onboard FiO₂ monitor.
• A portable touch button cough assist, using the Ventec One-Circuit, that allows patients to use the same circuit for ventilation and cough.
• A portable hospital-grade suction system that provides quiet and effective airway clearance with consistent and precise vacuum pressure; and
• A portable nebulizer that automatically compensates for the airflow from the ventilator when the nebulizer drive is active to ensure accurate ventilation.

According to Ventec, caregivers can seamlessly switch between therapies with the touch of a button and no longer need to change the patient circuit between therapies.

“I’ve seen firsthand how improved ventilator technology can enhance the quality of life for patients and caregivers,” said founder and Ventec CEO Doug DeVries, whose father was diagnosed with ALS. “Our team didn’t want to create just another ventilator, we spent the past five years focused on building a truly integrated solution.”

The device will ship to patients and caregivers beginning in June 2017, according to Ventec Life Systems, which noted that VOCSN is engineered and manufactured in the United States with eight pending patents.

More information is available on the company’s website.

A recent study found significant decreases in both hospital and payer costs and hospitalization rates for severe COPD patients post-discharge using advanced noninvasive ventilation (NIV) — specifically Philips Trilogy 100 with AVAPS-AE mode, compared to no NIV or the use of less advanced NIV therapy.

The results, announced by Royal Philips, revealed that both hospitals and payers can benefit from significant reductions in hospitalizations, readmissions and healthcare costs while also greatly improving the quality of care for patients living with COPD.

The Philips-sponsored study reviewed how hospitals and payers can more efficiently and effectively manage this COPD treatment and related comorbidities by implementing an advanced mode of NIV in the home care setting. This was reviewed in a multifaceted program that incorporates a combination of therapies including treatment using advanced NIV therapy provided by Philips Trilogy100 (AVAPS-AE modality), oxygen therapy, respiratory therapist-led care, patient education and medication reconciliation. This at-home program has now proven its potential to provide both hospitals and payers with tremendous savings while also offering the patient with treatment at home.

Key findings include:

• Hospital Savings: For a hospital covering 250 severe COPD patients, reduction of readmissions led to cumulative savings of $402,981 over 30 days and $449,101 over 90 days with a multifaceted therapy approach using Philips Trilogy in-home advanced NIV therapy versus no NIV treatment or less advanced NIV therapy devices. After examining 1,000 COPD patients being treated with this same combined treatment method using Trilogy, hospitals saved $1.6 million in the first 30 days and $1.8 million in 90 days compared to no NIV treatment or less advanced NIV therapy devices.
• Payer Savings: Payers studying admissions of 100,000 severe COPD patients had cumulative 3-year savings of $326 millionwhen using home NIV in comparison to no NIV treatment. Additionally, payers saved $1.04 billion cumulatively when using home NIV treatment compared to using a less advanced NIV therapy device over a three year period.

“The multifaceted and connected home NIV model described in this study can be easily adopted by other medical facilities and payers, and is expected to have a meaningful impact on both clinical outcomes and healthcare costs,” said Dr Teofilo Lee-Chiong, pulmonologist and Chief Medical Liaison, Philips. “As health systems continue to promote value-based care, it is increasingly important to demonstrate that programs like these can reduce costs while improving patient experiences using economic studies.”

Vyaire Medical Inc has acquired Ciel Medical Inc of San Carlos, Calif, a medical device company focused on solutions for medical professionals caring for intubated patients. Terms of the transaction were not disclosed.

According to Vyaire, Ciel Medical has developed innovative technologies that will strengthen its strategy to offer products that can help reduce the incidence of ventilator-acquired pneumonia (VAP) for ventilated patients.

“[VAP] costs the US healthcare system billions of dollars annually and Vyaire is committed to reducing overall costs of care while improving patient outcomes,” the company said in a press release. “Vyaire management sees the acquisition of Ciel Medical as a step toward the company’s stated goal of becoming the global leader in the respiratory care market.”

More information is available on the Vyaire Medical website.

In April, Ventec Life Systems launched its new respiratory care device, VOCSN, which incorporates five product technologies into one device, including ventilation, oxygen therapy, cough assist, suction, and nebulization. RT spoke with Doug DeVries, founder and CEO of Ventec Life Systems, about the new product, the launch, and the ventilation technology market as a whole.

RT: How is today’s ventilation technology responding to challenges like alarm fatigue, VAP, asynchrony, and more, while improving patient safety and quality of care?

Doug DeVries, Ventec Life Systems

Doug DeVries: VOCSN is designed with patients and caregivers in mind and seeks to reduce some of the age-old problems in respiratory care.  Reducing five devices into a single device relieves the stress on caregivers of learning multiple operating systems, managing multiple circuits, and responding to multiple alarms.  This integration allows caregivers to spend less time managing five different devices and responding to alarms on multiple machines and more time focusing on patients.

VOCSN was designed to reduce the risk for circuit misconnects and infection due to frequent breaks in the circuit. Caregivers can seamlessly switch between therapies with the touch of a button and no longer need to change the patient circuit between therapies.  For example, to administer a cough therapy, clinicians can simply press a button on VOCSN and use the Ventec One-Circuit rather than switching between multiple devices and circuits.  VOCSN makes cough therapy available to patients who may have previously avoided cough due to the time, effort, and anxiety of disconnecting from their ventilator.

RT: Tell us about your company’s new ventilator and about the advantages it offers for clinicians. What advantages does an integrated device have over stand-alone ventilators?

DeVries: VOCSN is more than just a ventilator, it’s a truly unified respiratory system that integrates five separate medical devices, including a critical care ventilator, 6 LPM equivalent oxygen concentrator, Touch Button Cough assist, hospital grade suction, and high performance nebulizer. VOCSN is designed to be meet or exceed the performance of traditional, stand-alone machines. Moreover, VOCSN is fully customizable—patients can get all five therapies or just the mix of therapies needed.

Ventilator patients often need more than just a ventilator.  Patients typically need multiple devices, power cords, patient circuits, and accessories which significantly impede mobility.

VOCSN is more than 70% lighter and smaller than existing machines, features a nine-hour on-board battery, and is controlled through an intuitive touchscreen interface and user-friendly operating system.

Integration not only reduces size and weight, it makes care easier. Switching between five devices to provide therapies is time consuming and uncomfortable. For example, a patient with a spinal cord injury using traditional technologies needing cough therapy must complete three steps. First, caregivers disconnect the patient from the life support ventilator. Second, the patient is connected to the cough assist device using a separate patient circuit. Third, once the therapy is complete, the patient must reconnect to the ventilator. Switching between devices may take up to 15 minutes, require as many as two caregivers to complete, and expose the patient’s airway to the risk of infection.

The VOCSN Touch Button Cough is activated with the touch of a button to make airway clearance easy. By unifying ventilation, cough, and suction into one system, it now takes seconds instead of minutes to administer cough therapy with Touch Button Cough. Patients remain connected to the ventilator at all times, and there is no need to disconnect circuits between uses. The system is designed to reduce the gaps in ventilation, decrease the risk of patient misconnection, and minimize exposure to the patient’s airway.

RT: Who are the primary patient populations your device is targeted toward? Are you targeting clinical settings and DME/home care providers evenly?

DeVries: VOCSN works across the continuum of care, from the hospital to home, and for pediatric patients weighing more than 5 kg to adults.  VOCSN is designed to provide care for patients with neuromuscular disease (eg muscular dystrophies, ALS), impaired lung function (eg COPD, CF, lung cancer, emphysema), spinal cord injury, and pediatric development complication (eg premature births, chronic lung disease).

The everyday mobility of VOCSN allows patients and caregivers to have all five therapies accessible at all times – whether a parent needs suction for their child during a car ride or a respiratory therapist needs oxygen for a patient during a hospital elevator ride.

VOCSN was designed as a critical care ventilator with both pressure and volume control modes for complex patient needs in a hospital or long-term care facility.  The compact size and extended battery power make it easier to transport patients. The internal 6 LPM equivalent oxygen concentrator and easy-to-use operating system simplifies patient management in the home.

RT: How/when is your device being rolled out? Is the product reimbursable through CMS and private insurers?

DeVries: Over the next year, we are working with select partners on a controlled rollout to maintain a close connection between patients, caregivers, and the team that created VOCSN.

We will work directly with each patient to monitor the VOCSN experience from the hospital to the home. Feedback from this period will help our team to continually redefine respiratory care.

All of 2017 production is fully committed to select domestic and international partners and we will begin shipping in June to the first VOCSN patients. VOCSN is FDA 510(k) cleared and we are working closely with CMS on reimbursement.

RT: What factors do you recommend hospitals consider when deciding to purchase or upgrade their ventilation equipment?

DeVries: Anything that saves time, reduces costs, and enables improved patient outcomes is indispensable in the hospital. The integration of VOCSN reduces time spent on training, maintenance, cleaning, monitoring, and providing care. Saving time reduces hospital costs and allows more time to focus on patients. Having access to all five devices within VOCSN provides peace of mind, reduces storage requirements, and limits time-consuming equipment searching and tracking.

RT: What changes and improvements are in store for ventilation technology in the future? What do you see with ventilation devices in the next few years?

DeVries: Global business and societal trends related to integration, remote technology, and customization are finally beginning to improve ventilation technology.  These trends are impacting consumer and clinical demand and will make current ventilator technology obsolete. Improved respiratory technology will facilitate everyday mobility for patients, improve patient compliance and tracking, and give patients the opportunity to focus on their relationships with loved ones and live their life.

Patients need more than just a portable ventilator. The integration of five devices with VOCSN is the beginning of integration, but the opportunity exists to further integrate additional monitoring and therapy accessories. Integrating respiratory equipment and data with other nonmedical equipment and devices—such as smart wheelchairs—will produce comprehensive solutions that empower patients to take control of their care.

The proliferation of connected devices is expanding the possibilities for remote monitoring and telemedicine. VOCSN is equipped with Wi-Fi and Bluetooth technology not currently enabled. As remote monitoring technology matures and the regulatory environment evolves, VOCSN will support secure remote patient and device monitoring.  Seamlessly connecting patients, caregivers, and devices will provide greater access to care and increased patient engagement.

Finally, the current one-size-fits-all device approach that requires clinicians and caregivers to “trick” machines to work for their patients will soon be supplanted by specialized systems that are customized for specific patient populations. Advances in manufacturing and software have opened up the capabilities for customization which will drive demand for patient-centric devices. RT

For further information, contact RTmagazine@nullallied360.com