A Step Closer To The Future

The ventilators of the future may not look very different from today, but several features will clearly separate them from the current generation of ventilators.

Even though the concept of mechanical ventilation dates back to the 14th century with Vesalius, it is only in the last century that it has been widely introduced into routine clinical practice. Since their initial appearance, mechanical ventilators have become more sophisticated and expanded their application from the intensive care unit (ICU) to the respiratory medicine ward and even to patients’ homes for long-term treatments. This was the result of combining the advances in our understanding of respiratory physiology, pathophysiology and clinical management of patients together with technological progress in mechanical, electronic and biomedical engineering.

Nowadays, this evolution is still rapid, with new devices and an increased number of ventilation modes and strategies being introduced to improve outcomes, patient–ventilator interactions, and patient care. Engineering has played and is still playing a relevant role in this process, not only in improving the technical performance of the ventilators but also in contributing to a better understanding of respiratory physiology and pathophysiology, and of how different ventilation strategies interact with the respiratory system.

The computer-based technology has made the modern-day ventilators even more doctor and patient friendly. The synchronized ventilators with volume control and or volume guarantee with advanced pulmonary graphics have helped to make weaning from ventilators easier with lesser side effects. Nowadays, ventilators can be connected with central monitors and can be monitored sitting at a distance as well. The concept of E-ICU wherein the monitoring system is electronic, digital, and real time is likely to pick up in the near future.

The concept of gentler ventilation has increased the demand of a CPAP system and heated humidified high-flow nasal cannulae. Many neonatal and pediatric conditions are helped by these relatively simple ventilation techniques. There is more scope of high-frequency ventilators in current day NICU and PICU care and the need of the hour is to have cost-effective high-frequency ventilators. T-piece resuscitators have replaced self-inflating bags in labor rooms and they are being used as transport ventilators also. With the rising cost of intensive care and many sick children requiring home ventilators, we need to build an appropriate medical support system to help such practices.

One of the major challenges an Indian intensivist faces today is to balance the level of care and its financial implications to the patient. There is a need for making cost-effective ventilators with low running cost. With wider spread availability of ventilators all across the country, increased incidence of healthcare associated infections including ventilator-associated pneumonias has been observed. There is a great need to impress upon the new generation that there is no replacement of infection prevention strategies in improving the survival and reducing morbidities.

Indian market

The Indian ventilators market in 2017 is estimated at 8075 units, valued at Rs. 420 crore. The imported equipment continues to dominate the segment with a 77 percent share by value, and a 62 percent share by units.  The ambulatory and transport models too are seeing a gradual increase in demand. In India, contrary to general perception, refurbished and indigenous ventilators, continue to cater to a niche, regional segment, albeit support as warranty, after sales service, and spare parts availability are now the differentiators among these brands. The popular refurbished models are Evita and Savina series from Draeger; Servo i from Maquet, Puritan Bennett’s 840, and Engstrom from GE. Other models, which are also popular are Verasamed from GE, a couple of models from Siemens, and Evita 2 and Evita 4 from Draeger. Overall, across all segments with intense competition, margins are being compromised as prices are increasingly going south.

The government continues to be a large buyer. Safdarjung Hospital, New Delhi ordered 143 units of high-end systems for its new block on BD India. Getinge was awarded an order for about 200 units by HLL.  Mindray received an order for 147 units from KDLWS (Karnataka Drugs and Logistics Wavehousing Society); 100 units from TSMISC (Telengana State Medical Infra); and 45 units from Gujrat Medical Services Corporation Limited (GMSC). Air Liquide too received an order for 26 units from KDLWS.

Maquet continues to dominate the segment. Moving forward, Vyaire Medical, with such a wide spectrum of products is expected to be aggressive in this segment. In October 2016, BD (Becton, Dickinson and Company) and Apax Partners had announced the launch of a joint venture – Vyaire Medical – a standalone, global respiratory solutions company. The closing finalized the sale of 50.1 percent interest in BD’s Respiratory Solutions business. Vyaire Medical includes all business lines within BD’s Respiratory Solutions business, including Ventilation, Respiratory Diagnostics, Vital Signs, and AirLife. BD retained a 49.9 percent minority interest in the new company. BD had thus successfully off-loaded the respiratory business acquired in its CareFusion purchase. In April 2017, it acquired Ciel Medical, Inc., of San Carlos, California, a medical device company focused on solving unmet needs of medical professionals caring for intubated patients. And, in October 2017, the company acquired Revolutionary Medical Devices, Inc. (RMD), of Tucson, Arizona, a maker of innovative products for airway management. In April 2018, Vyaire Medical acquired Acutronic Medical Systems a Switzerland and Germany-based leader in the design and manufacture of neonatal ventilation equipment.

Global market

The global ventilators market is projected to reach USD 1261.9 million by 2023 from USD 859.9 million in 2018, at a CAGR of 8.0 percent, estimates MarketsandMarkets. Rising prevalence of respiratory diseases, increasing incidence of preterm births, urbanization and growing pollution levels, high prevalence of tobacco smoking, rapid growth in the geriatric population, and rising number of ICU beds are the major factors driving the growth of the ventilators market.

On the basis of mobility, the intensive case ventilators segment accounted for the largest share of the global ventilators market. The large share of this segment is attributed to the rising number of ICU beds and rising adoption of equipping the ICU beds with ventilators.

The need to render treatment to critical patients at the point of emergency is driving the transport mechanical ventilators segment. The increasing practice of transfer patients on ventilator support from hospital settings to alternate care for financial gains of hospital administration is propelling the demand for portable mechanical ventilators.

On the basis of interface, the invasive ventilation segment accounted for the largest share of the ventilators market. The large share of this segment is due to the high prevalence of tobacco smoking, increasing prevalence of chronic diseases such as COPD and asthma, rapid growth in the geriatric population, and improving healthcare affordability in developed countries.

By end user, the hospitals and clinics segment accounted for the largest share of the ventilators market. The large share of this segment can be attributed to the increasing number of private and public hospitals, economic expansion and focus of government on broader healthcare policies, and increasing per capita income.

By type, the adult/pediatric ventilators segment held the largest market share of ventilators market. The large share of this segment can be attributed to the large patient population with severe COPD, asthma, and other chronic respiratory diseases; rising number of smokers; and rapid growth in the geriatric population.

North America accounted for the largest share of the ventilators market in 2017, followed by Europe and Asia-Pacific. The presence of major market players, the rising geriatric population, high prevalence of smoking, high prevalence of respiratory diseases, highly developed healthcare system, and high healthcare expenditure are the other factors responsible for the large share of North America in the ventilators
market.

The prominent players in the global ventilators market are Philips Healthcare, ResMed, Medtronic, Becton, Dickinson and Company, Getinge, Draeger, Smiths Group, Hamilton Medical, GE Healthcare, Fisher & Paykel, Air Liquide, Zoll Medical, Allied Healthcare Products, Airon, Mindray, and Schiller.

Technological advancements

The historical development of the mechanical ventilator is truly a remarkable journey. In just 50 short years the industry has gone from relatively crude, totally mechanical devices that could provide only machine-triggered volume ventilation to highly evolved microprocessor controlled systems capable of any form of ventilatory support imaginable. The evolution of the mechanical ventilator mirrors the evolution of the profession of respiratory care as well as critical care medicine, and may even be the primary reason that respiratory care has grown to its current status. The ventilator of the future may not look very different from today, but several features will clearly separate them from the current generation of ventilators.

Since the iron lung, respiratory equipment has limited the mobility of ventilator patients. However, recent portable devices may combine various respiratory therapies such as ventilation, oxygen, cough, suction, and nebulization. The devices are controlled through an intuitive touchscreen interface and user-friendly operating system. Caregivers can seamlessly switch between therapies with the touch of a button and no longer need to change the patient circuit between therapies.

New portable life support ventilators are lighter and smaller providing invasive, noninvasive, and mouthpiece ventilation. Designed to work in hospital, institutional, transport, and home environments, they deliver a comprehensive set of ventilation modes and settings to meet patient needs. The advanced ventilation technology combines responsive leak and circuit compensation as well as precision flow trigger controls to enable comfortable breathing and accurate therapy.

Manufacturers are developing wirelessly connected portable ventilators to have a meaningful impact on patient outcomes. Connecting to cloud-based patient management application, the current Bluetooth-enabled devices turn medical-grade data into actionable information, delivering it directly to mobile devices or desktops of care providers multiple times per day. This solution enables care teams to monitor patients remotely and proactively, allowing for fast and informed clinical decisions including early intervention, which can help avoid unnecessary readmissions and lower cost of care.

Mechanical ventilators are often one of the major sources of an alarm and several manufacturers have developed technology to reduce the incidence of non-actionable alarms. Ease of use within the context of alarm management is a key to patient safety. While ventilators have default alarm settings, the ability to customize those settings is important. Modern devices have an intuitive and simple touch, turn, and confirm interface to allow the user to change parameters. Users can customize settings to suit the needs of the individual patient.

To cover the gap from conventional turbine ventilator to versatile ICU ventilator, many enhancements have been done in areas of lung protective strategies by integrating specific modes like airway pressure release ventilation (APRV) and pressure regulated volume control SIMV (PRVC-SIMV) in conjunction with special maneuvers such as PV tool, occlusion pressure, negative inspiratory force, intrinsic PEEP, etc. In addition, synchrony tools and leak compensation ensures an outstanding non-invasive ventilation performance. To address cross-contamination issue from infectious patients, leading manufacturers improvise the design further by developing detachable and steam-sterilizable inspiratory, expiratory valves, and flow sensor.

The rationale of intelligent ventilators is to improve patient management by analyzing and integrating information coming from large number of sources, and guaranteeing continuous adjustment of the ventilation even when expert personnel are not constantly available, improving patients’ treatment and minimizing clinical errors. Engineering science has developed several computational tools that start from a set of input (measured) variables and can determine the desired outputs (settings) that can be used to model the cardiorespiratory system and/or the decisional process of the clinicians to automatically identify an optimal ventilation strategy.

Outlook

Moving forward, ventilators are expected to be miniaturized into a single chip, which can also be used for ECG and EEG monitoring, offering enhanced portability to enable transport from one healthcare facility to another. Low-power design using smaller batteries, longer backup time, wireless connectivity to enable remote monitoring from a distant site coupled with leveraged technical expertise, and minimized onsite repair visits could be the focus in coming years.

Emphasis on developing devices, incorporating distinctive and proprietary algorithms for new modes of ventilation with adaptive facilities for each patient based on variants and combinations of the classical pressure and volume control modes, could be in limelight in the years ahead.

On technology front, high-flow oxygen therapy mode could be useful to power a high-flow continuous positive airway pressure system accurately, avoiding the use of a less reliable gas blender or venturi-based flow generator. With an adequate humidifier, this mode can also be useful to drive high-flow nasal cannulas, a tool that is expected to have a major role in research and clinics in the next few years.

Industry Speak
Emerging Trends In ICU Ventilators

In modern day an ideal ventilator should maintain the much-needed patient-ventilator synchrony and ensure superior patient comfort. Our range of ventilators not only offer the latest advances in technology, are compact in size and offer features to meet the demands of critical care applications. The choice of invasive and non-invasive ventilation modes makes a ventilator ideal for universal use on adult to pediatric patients.

An ideal ventilator should focus on safety and patient comfort by way of its advanced modes and therefore meet the challenge of different critical situations. Modern day ventilators offer advance modes of ventilation like PACV, PSIMV, VACV, VSIMV, AUTO (Emergency Quick Start), Spont+, PRVC, ACPAP+, suitable for Invasive and non-invasive ventilation. Availability of enhanced monitoring screens by way of additional graphical display screens aid the intensivists in better monitoring. Availability of SpO₂ and ETCO₂ Monitoring are an added advantage.

The last decade has witnessed a steady rise in demand for high-performance turbine-based models. Trigger function and pressurization quality work better with turbine-based ventilators. We have designed turbine-based ventilators with a shorter triggering and inspiratory delay and a higher PTP (the amount of assistance received by the patient during the initial part of the effort). In circumstances where availability of oxygen is a problem turbine-based ventilator are better suited as they work on low-pressure oxygen source. New-generation turbines are compact in size with low noise level and high-peak flows to guarantee uncompromised ventilation to meet flow demand on breath onset during spontaneous ventilation.

Ventilators suitable with both dual as well as single limb breathing circuits are more versatile for use. Patient history storage capability, automatic parameters adjustment of patient according to height and weight, O₂ streaming assisted therapy for weaning and pediatric weaning, leakage and hose system automatic compliance compensation are features one should look out for.

Aditya Kohli
Director – Sales & Marketing,
Allied Medical Limited

Industry Speak
Advancements And Emerging Trends In Mechanical Ventilation

Ventilation, more specifically mechanical ventilation has been a key component of critical and super-critical care for decades. The focus has long shifted on to how the machine can do more and how do we ensure better safety, sustainable performance, and faster weaning. Individual technologies for advanced measurements as well as more complicated mode algorithms have also surfaced as commonly used systems.

First and foremost, I would like to mention the type of breath which provides the assurance of volume delivery with the safety of pressure limiting, the Pressure Regulated Volume Control (PRVC) breaths. It works to achieve the set amount of volume delivery at the minimum pressure. In few cases, a similar mode called Auto Flow is also referred to. Looking at better ways to support a spontaneously breathing patient, the pressure support (PS) modes were already available, now volume support (VS) is also being practiced to ensure assured volume delivery with support. The technology has moved even more forward toward lesser and lesser interactions by a caregiver via algorithms like auto mode which automatically switches between support and control modes to achieve tighter PaCO₂ control.

As a next step to seamless control and absolute safety, the ultimate objective physiologically remains to be able to wean out and extubate as quickly as possible. Modes like mandatory minute ventilation (MMV) achieve faster weaning while ensuring fewer mandatory breaths and lower peak inspiratory pressures. Though developed as an algorithm targeted toward better weaning, there is no concrete scientific study result confirming the same. In a similar context we can look into algorithms like Smart Care, which strive to provide better comfort to a patient under support and utilize closed loop modification of pressure support ventilation with integrated artificial intelligence.

The system mimics clinical approach of adjusting ventilator assistance depending on patient’s respiratory pattern and literature-based weaning protocols. In common use BI-LEVEL and airway pressure release ventilation (APRV) ensure support for spontaneous breathing for the patient. The APRV mode ascertains dual functionality; in presence of spontaneous breathing the patient can breathe in any phase of respiratory cycle with supported breaths thus bringing down needs of sedation, else, APRV additionally acts as an inverse-ratio ventilation scheme for better recruitment.

Prasenjit Das
Manager- Marketing Support,
Skanray Technologies Pvt. Ltd.

Industry Speak
High flow Oxygen Therapy in Ventilators – A Demand Set To Rise

Ventilators has been traditionally looked upon as a typical life support device having two options for ventilation: Tube or mask. Low flow O₂ therapy with O₂ mask has been conventional way of maintaining blood gas balance. But in recent years medical industry has convincingly approved a new option in between traditional O₂ therapy and ventilators for acute respiratory failure patients or patient who require assistance with respiration to stabilize breath and control blood gases, this is known as High Flow Oxygen Therapy (HFOT).

HFOT have a lot of clinical advantages in terms of increasing EELV, decreasing dead space, significantly reducing the work of breathing and improving gas exchange apart from patient comfort and they can communicate normally with nasal cannula (HFNC) option. HFOT is not a very complex equipment, it only need a blender, gases, nasal cannula/oxygen mask and humidifier, where blender is capable of giving flows up to 60L/min. All these components are already a part of any ventilator so if we make use of ventilator like HFOT device we can give appropriate level of support to these patients. The addition of HFOT technique to ventilator make this technique more widely available and implementable technique with no extra cost to it. The same has been understood and used by some leading ventilator suppliers by providing O₂ therapy option in ventilators.

Integrating HFOT into ventilator gives additional benefits e.g. no need of change of device if mechanical ventilation needed, O₂ concentration does not need titration set absolute FIO₂ you set to deliver, avoid O₂ poisoning by monitoring FIO₂ and. Monitor patient saturation levels parameters to access outcome. HFOT can also help to avoid over usage of mask ventilation in do not intubate kind of patients and provide appropriate humidity to patients.

However, the purpose of adding HFOT into ventilator is not to replace mechanical ventilation but to compliment to it. With many studies proving the benefit of HFOT over conventional O₂ therapy shows the clear path of success and ventilator industry is also set to be benefitted by integration of the same.

Manju Goyal
National Application Manager – PMLS & SU,
Mindray Medical India Pvt. Ltd.

Industry Speak
Technological Advancement In Mechanical Ventilators

On market trends

From the latest scenario, it has been noted that the intensivists are rapidly moving toward non-invasive ventilation (NIV) and High Flow Oxygen Therapy (HFOT). Some of the key reasons for increased popularity of HFOT are that it is simple and easy to set up, causes minimal nasal trauma, and is well-tolerated by patients due to high humidity.

High-flow oxygen delivery has been clinically utilized in a wide spectrum of patient care. In recent times it has migrated into the home care environment due to the availability of portable HFNC standalone devices in the market. However, in a hospital environment, it is being preferred as a feature or a mode for smooth transition of NIV to invasive ventilation, as and when required, in high-end mechanical ventilators. HFNC is also proving helpful in supporting the oxygenation of hypoxemic patients and is being well-tolerated by children.

Today most of the mechanical ventilators are equipped with HFNC/oxygen therapy. HFNC expands the ventilator’s capacity during the pre- and post-intubation stages. A positive clinical effect on various respiratory parameters has been observed after the usage of HFNC and studies suggest that it may reduce the work of breathing as well.

On growth drivers

• The last 1 year has seen a definite rise in demand of respiratory support equipment. Some of the factors that have led to this upward surge are:
• Rise in chronic and acute respiratory diseases
• High penetration of health insurance schemes introduced by the government
• Increase in the number of corporate chain of hospitals and new medical collages like AIIMS in tier II cities

On challenges

Buyers continue to demand advance technology and user-friendly ventilators with low running cost, making their purchase cost-effective. Therefore, to meet the buyer’s demand with competitive pricing has become the biggest challenge in the market today.

Atul Jabde
Sr. General Manager – Ventilator Sales,
Schiller