INTERNATIONAL VENTILATOR USERS NETWORK
an affiliate of Post-Polio Health International
This issue sponsored by:
VOLUME 31, NUMBER 3
Norma MT Braun, MD, FACP, FCCP
Norma MT Braun, MD, FACP, FCCP, was invited as Visiting Professor to Kwong Wah Hospital, Yau Ma Tei, Hong Kong, by Dr. Daniel Ng, Chief of Paediatric Pulmonary and President of the Hong Kong Society of Paediatric Respirology and Allergy, for a week in March of 2017........MORE
In mid-April, the new VOCSN, described as a unified respiratory system, received its FDA 510(k) Clearance. VOCSN can provide pressure and volume support ventilation and much more.
Doug DeVries, CEO, founded Ventec Life Systems four years ago to make a ventilator that would be easier for caregivers to use based on his long career of developing ventilator technology...........MORE
Vol. 31, No. 3, June 2017
Editor: Joan L. Headley
Designer: Brian Tiburzi
Permission to reprint must be obtained from Post-Polio Health International (PHI) at firstname.lastname@example.org.
Ventilator users, health professionals, non-profits, company representatives – send comments and updates to email@example.com.
Dr. Braun Lectures in Hong Kong
Norma MT Braun, MD, FACP, FCCP
Norma MT Braun, MD, FACP, FCCP, was invited as Visiting Professor to Kwong Wah Hospital, Yau Ma Tei, Hong Kong, by Dr. Daniel Ng, Chief of Paediatric Pulmonary and President of the Hong Kong Society of Paediatric Respirology and Allergy, for a week in March of 2017.
Dr. Braun relates her experience.
Due to positive pressure noninvasive ventilation (PPNIV), many of their patients with neuromuscular disorders were surviving into adolescence and early adulthood. From years of use of various facial masks for sleep and some hours during the day, their faces were being molded by the masks, distorting not only their facial contours, but also their teeth.
Socialization needs and matriculating into more advanced schooling triggered a search for alternative modes of ventilation. Dr. Ng researched and reached out to determine if negative pressure noninvasive ventilation (NPNIV) could work.
Since I am one of the few physicians left who have had experience in this mode, I answered the call. They requested tutorials in long-term NPNIV.
I requested that the team caring for such patients be assembled along with healthy staff volunteers who would be used in trials of the negative pressure units they had acquired prior to my arrival.
I also asked for the patients who could potentially benefit from the NPNIV be a part of the workshop, too - real patients in real time.
The NPNIV units on hand came from the Italian company, Dima Italia, that manufactures their own pressure pump having dual function: both positive and negative pressures. They also provided a modified pneumosuit, chest cuirass and a pneumobelt. We also had a fiberglass lung from the US.
Figure 1. Dr. Braun, seated, center
While each was available in only one size, and these items had some design problems, they functioned well enough for the short time used for the trials as proof of principle. It was enough to illustrate the functional characteristics of each unit and to assess the effects on the volunteers and patients.
During my stay, I presented four lectures on the following topics:
Review of the complex normal respiratory anatomy and physiology systems used for breathing.
Review of the most common neuromuscular disorders and how to recognize when they have progressed to neuromuscular hypercapnic respiratory failure that could benefit from NPNIV.
Presented research on how respiratory muscles are spared and their function supported in these patients when using different forms of NPNIV, including PPNIV from pneumobelts and a video of a patient in a rocking bed.
Presented long-term data of real patients, including family education for stable home care, nutrition and rehabilitation.
I also consulted on a ventilator-assisted 19-year-old with cerebral palsy, a patient with idiopathic scoliosis, and a young child with tracheomalacia for assessment and management.
Their interest was intensive. They have no respiratory therapists in their health care system. Nurse practitioners are the senior nurses and, under the direction of the physicians, place the patients on ventilators, adjust and monitor them, record the experiences, and attend to all the other needs of the patients.
These nurses are the ones in white who still don the signature of their profession, a nurse’s cap. Theirs are made of paper so they can be discarded with no fear of bacterial contamination. (Figure 2)
The team consisted of Dr. Ng, Chief, his next in command, pulmonologist, Dr. Eric Chan, and a neurologist, nurse respiratory practitioners, a nurse pulmonary function technologist, a nutritionist, physical and occupational therapists and a social worker. (Figure 1)
They had prepared eight different patients; one or two patients for each half-day session, and each had a voice, albeit soft, in the trials.
Every volunteer and patient had their oxygen levels assessed by oximetry and their end-tidal carbon dioxide levels assessed pre, during and post-trials of the equipment.
Since there was only one size of each type of negative pressure system, a “best fit” was the basis for the selection. The team took time with each patient, explaining and then allowing for acclimation and comfort.
All were outpatients and the disorders included Spinal Muscular Atrophy type 1, 2 and 3, myofibrillar myopathy (MFM) and Duchene’s Dystrophy.
Voluntary cough peak flows were assessed by a Wright Spirometer, contributed by Lou Saporito, RRT, who came from Dr. John Bach’s service at Rutgers New Jersey Medical School. Saporito is very experienced with noninvasive ventilation and offered a perspective as a professional respiratory therapist, adding to the team approach.
The need for developing adequate cough support by breath stacking, Ambu bag use, and/or manual methods was demonstrated and tried.
As expected, we found that patients can use more than one system based on their needs and lifestyle, e.g, NPNIV for sleep and PPNIV in the daytime.
Another alternative was to use a pneumobelt, which applies positive pressure via the abdomen for active exhalations with deflation for passive, gravity assisted inspirations. The device allows for daytime use while sitting and relieving the face from the night-time device and to augment cough.
The patients were accustomed to their PPNIV, using it for sleep and, increasingly, in the day as well. Their distorted faces bore the marks of their compliance with ventilator use.
They had a sense of humor, stating their goals for a more normal life, pursing advanced education and for easier socializing with peers. Their easy manner and interaction with the team reflected the level of confidence they had with their health providers. An open attitude with the patients and their families was evident. There was a mutual respect that is needed to make noninvasive ventilation work.
There was a learning curve with becoming confident in using NPNIV for both patients and the health professional team as the patients can talk when the systems are operating. The problems that were encountered were adequate sealing to prevent air leaks, pressure points with friction in mostly very thin patients, and attaining patient comfort levels and a sense of trust in a new system.
All patients achieved respiratory satiety when the ventilator pressures were set to satisfy their sense of enough air resulting in low normal levels of end-tidal CO2, as I found when I was doing research on such patients.
None developed upper airway obstruction, although none fell asleep during the daytime trials. (When one of my prior patients developed upper airway obstruction because of a weight gain of 35 pounds after two years of successful nightly NPNIV use with a pneumosuit it was circumvented by 5 cm H20 of CPAP.)
I left the team with optimism about the application of NPNIV that would be facilitated by the following improvements:
A better design of the pneumosuit to include a) the arms to the wrists and legs to the ankles to prevent numbness and swelling, b) a longer chest cage to allow better diaphragm descent, and, c) a more adjustable neck for better sealing of leaks, reducing the patients feeling cold.
Improve design of pneumobelt by adding more adjustable straps to sustain the fit for better pressure compression of the abdomen for bigger breaths.
A softer neck seal in the fiberglass lung.
Better padding of the cuirass cage edges for less friction and greater comfort and adding a cushioned back plate for better trans-chest cage pressure gradient delivery.
These suggestions for improving the systems were conveyed to Dima Italia.
I will have an opportunity to assess the outcomes of their efforts in October of this year when I will be returning to Hong Kong to deliver an invited lecture on NPNIV to the Twentieth Anniversary Meeting of Asia Paediatric Pulmonology Society, which encompasses the countries of Southeast Asia.
Five in One: A Unified Respiratory System
In mid-April, the new VOCSN, described as a unified respiratory system, received its FDA 510(k) Clearance. VOCSN can provide pressure and volume support ventilation and much more.
Doug DeVries, CEO, founded Ventec Life Systems four years ago to make a ventilator that would be easier for caregivers to use based on his long career of developing ventilator technology.
Christopher T. Kiple, Chief Operating Officer, and Chris Brooks, Managing Director, Ventec Life Systems, Bothell, Washington, answered IVUN’s questions about the VOCSN.
What input did the company gather from ventilator users when designing and creating the VOCSN?
The Ventec team is motivated by the belief that people are more than their medical conditions and that technology should evolve to make life easier. People should not have to use five different medical devices to treat any medical condition. And yet, the reality has been very different.
Hospital workers must learn multiple devices and spend valuable time switching circuits to deliver multiple therapies. Patients' families are overwhelmed as their homes turn into mini hospital rooms to support all of the different devices. Ventec designed VOCSN to make life easier for patients and their caregivers. The result is that patients become more mobile and caregivers and families have more time for life’s activities.
Ventec conducted hundreds of user tests to inform the design of the physical features of VOCSN and the VOCSN operating system. Based on the feedback, Ventec developed an easy-to-use and approachable touchscreen that operates much more like a smart phone than a medical device.
Additionally, the Ventec One-Circuit™ eliminates the clutter of several cumbersome tubes connecting to separate devices to create one easy-to-manage system which provides peace of mind.
Everything in VOCSN was built from the ground up to be easier to use for patients and caregivers. New technology was developed to provide best-in-class treatment in a smaller, more energy efficient system. VOCSN is engineered and manufactured in the United States with eight pending patents.
Having fewer devices in the home or when traveling appeals to many long-time ventilator users. Describe the five therapies in the one device.
VOCSN integrates five separate medical devices, including a ventilator, oxygen concentrator, cough assist, suction, and nebulizer, into the first portable unified respiratory system designed for respiratory care from the hospital to home.
VOCSN is FDA cleared for pediatric patients weighing more than 5 kg to adults. The device 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.
Patients can get all five therapies or just the mix of therapies needed. It is designed to improve care for patients with neuromuscular disease (e.g., Muscular Dystrophies, ALS), impaired lung function (e.g., COPD, Cystic Fibrosis, Lung Cancers, Emphysema), spinal cord injury, and pediatric development complication (e.g., premature births, Chronic Lung Disease).
With VOCSN, ventilator users and their caregivers can seamlessly switch between therapies with the touch of a button and no longer need to change the circuit between therapies. Caregivers spend less time managing machines.
VOCSN is a portable critical care ventilator that provides invasive, noninvasive, and mouthpiece ventilation. Designed to work in hospital, institutional, transport, and home environments, it delivers a comprehensive set of ventilation modes and settings. The advanced ventilation technology combines responsive leak and circuit compensation as well as precision flow trigger controls to enable comfortable breathing and accurate therapy.
VOCSN is portable oxygen concentrator that delivers the equivalent of 6 L/min of oxygen. The VOCSN Oxygen-Direct™ system is up to three times more energy efficient than existing concentrators. In addition to the on-board internal oxygen concentrator, external oxygen sources can be connected to VOCSN for critical care patients. It also includes an onboard FiO2 monitor to verify accurate oxygen delivery.
The Ventec One-Circuit™ features a high flow valve design, allowing patients to use the same circuit for ventilation and cough. Using the Cough + Suction feature and Ventec Secretion Trap, suction therapy is activated during the cough therapy to clear secretions. Once the set number of cough cycles is complete, ventilation automatically resumes.
The VOCSN hospital grade high flow suction provides quiet and effective airway clearance with consistent and precise vacuum pressure. The suction system, together with the Ventec Secretion Trap, simplifies mucus management by allowing patients to remain connected to the same circuit during ventilation, cough, and suction therapies.
The advanced sound muffler in VOCSN makes suction therapy more than three times quieter than traditional suction machines.
VOCSN is high performance nebulizer that automatically compensates for the airflow from the ventilator when the nebulizer drive is active to ensure accurate ventilation. VOCSN records data about each treatment and automatically turns off the nebulizer once the therapy timer is complete.
How soon will the VOCSN be available and what will it cost?
Over the next year, Ventec Life Systems will work 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 the team to continually redefine respiratory care.
Ventec Life Systems is working closely with the Centers for Medicare & Medicaid Services (CMS) to development a reimbursement plan for VOCSN. VOCSN is designed to be a more cost effective solution than purchasing five separate devices.
Visit www.venteclife.com/reserve for more information to place an order to reserve or schedule a demonstration.
VENTILATOR USERS SPEAK
“I’ve been having problems with the ‘screen saver’ on my Trilogy 100. The screen is set to go black after 5 min so that I can sleep without a bright light in the room.
“This worked for several weeks and then the ‘screen saver’ would not kick in and the light would stay on. I had the respiration therapist (vendor) come in and try to make it work. Sometimes he could fix it and sometimes he could not. We even sent one machine back and the therapist was told that it worked when they got it. After two weeks the new machine had the same problem.
“We just got off the phone with Philips (manufacture of the Trilogy) and they explained that it was a known problem and the software fix was being worked on. Until then they gave us a work around that worked just now. (I hope it continues to work, its better than putting a towel over the machine.)
“If screen saver is not working (the display stays lighted up),
Turn on machine.
Pull the plug and wait until the alarm sounds
Plug machine back in
Reset the alarm and wait five min for the screen saver to kick in.”
Response from Jeff Marshall, Sr. Field Marketing Manager, Philips Respironics, June 27, 2017:
“The above issue has been corrected on a released software version 14.2.02. This was launched 2 weeks ago.”
NEWS FROM IVUN
Call for Proposals for PHI Research Fund Grant
Deadline for 2018: October 2, 2017 (Monday)
Funding in the amount of $50,000 is available from Post-Polio Health International and International Ventilator Users Network for research to be completed in 2018. Application for the funds must be received by October 2, 2017.
Researchers can choose to apply for one of the two grants described below.
The Thomas Wallace Rogers Memorial Respiratory Research Grant to study the management of neuromuscular respiratory insufficiency or to explore historical, social, psychological and independent living aspects of long-term home mechanical ventilation
The Post-Poliomyelitis Research Grant to study the cause(s), treatment and management of the late effects of polio or to explore historical, social, psychological and independent living aspects of living with polio.
Applicants may apply for $100,000 for a study taking two years to complete.
The research must have the potential to improve the lives of polio survivors or users of home mechanical ventilation.
For details on the application process and to access the form, see www.polioplace.org/phi-funded-research/new-request-2018-award.
You may also review the summaries and final reports of previous recipients of The Research Fund.
The Research Fund is supported by polio survivors, users of home mechanical ventilation and their families. Find out more about how you can support The Research Fund.
Message from Board of Directors
Joan L. Headley has announced her retirement, effective September 1, 2017. She began her work with organization in 1987 and has been Executive Director of Post-Polio Health International for 28 years. “Joan Headley has been in a real way the heart of PHI for nearly three decades,” PHI’s Board of Directors said. “She will be greatly missed.”
The Board also reaffirmed “our mission of providing accurate and reliable information regarding post-polio syndrome and home mechanical ventilation through Polio Place (polioplace.org and ventnews.org) and through direct contact with our staff in St. Louis.”
Click here to learn more about the position and how to apply. The deadline to apply is July 17th.
Family Voices, Inc.
With the United States in the throes of determining the future of healthcare for all, there are national groups advocating on behalf children and adults with disabilities. The discussion about Medicaid and the related cuts, including per capita caps and block grants would disproportionately affect children and adults using home mechanical ventilation.
To learn more about the specifics and to become involved, check out the advocacy of Family Voices, Inc.
They state that “It’s almost impossible to pinpoint when things for children and youth with disabilities began to change. Was it when the Children’s Bureau was established in 1935 and ‘crippled children’ (its term) were acknowledged as present and deserving of care and attention? Was it decades later, in the 1960s, when the Civil Rights Movement caused people to think about discrimination of any kind? Or later in the 1960s when Medicaid was created? Was it the events leading up to the passage of the federal special education law, P.L.94-142 (now called IDEA) in 1975?
“In any case, by the end of the 1970s, families and many of their professional partners agreed that children, disabled and nondisabled, with chronic health conditions and without, belonged with their families, in their communities, and with their friends. They belonged at home.”
To find resources in your state, go to www.familyvoices.org/states.
Also check out their Facebook page for updates on healthcare legislation and advice for actions.
Alice Wong, featured in IVUN’s Ventilator-Assisted Living, Volume 31, Number 2, “Meet Alice Wong,” was published in The New York Times, on May 3. Her essay was posted with her permission on the website of DREDF, an advocacy organization for people with disabilities following the healthcare debate. Alice’s essay is entitled “My Medicaid, My Life.”
The Potential Impact of the AHCA on Home and Community-Based Services Spending
“If per-enrollee caps like those proposed in the American Health Care Act had been imposed in the mid-2000s, they would likely have caused many states to restrict HCBS spending to amounts far lower than spending under existing Medicaid reimbursement rules. States spending the lowest amounts initially—those likely most in need of improvement—would have been among the hardest hit, either in terms of reduced Federal reimbursements or having to abandon plans for building a more robust HCBS system.” Download the full report from the University of California, San Francisco’s Community Living Policy Center.
For students with disabilities in the US
The U.S. Department of Education launched a new website dedicated to dispersing information on the Individuals with Disabilities Education Act (IDEA). The updated resource, which is based on feedback from parents, educators, disability advocates and other stakeholders.
On March 27, 2017, President Trump signed Public Law No. 115-13, which rescinded the Department of Education’s regulations relating to accountability and state plans under the Elementary and Secondary Education Act of 1965, as reauthorized by the Every Student Succeeds Act (ESSA). In order to reflect these changes, OSERS has revised and is reissuing “A Transition Guide to Postsecondary Education and Employment for Students and Youth with Disabilities” to remove references to the now rescinded ESSA regulations.
aRealOnlineDegree.com is a website dedicated to providing students with resources for college. They have an extensive 2017 resource page for college students with disabilities. It covers everything that students with disabilities need to know before attending college, both in-person and online.
Magazine for Parents
Exceptional Parent Magazine provides practical advice, emotional support and the most up-to-date educational information for families of children and adults with disabilities and special healthcare needs. All 25 previous months issues are available to read online or to print.
Also, you can subscribe to EP-Magazine.
Parent Project Muscular Dystrophy 2017 Annual Connect Conference
June 29 to July 2, 2017, Chicago, Illinois. Save the date.
European Respiratory Society (ERS) International Congress 2017
September 9-13, 2017, Milan, Italy. Registration is open.
FOCUS Fall 2017
September 28, 2017, Doubletree Hilton Hotel, Monroeville, Pennsylvania. Watch for details.
October 18, 2017, Poughkeepsie Grand Hotel in Poughkeepsie, New York. Watch for details.
October 28- November 1, 2017, Toronto, Canada. CHEST annual meeting offers more than 400 general sessions, postgraduate courses, simulation education sessions, original investigation presentations, CME/CE credits and MOC points for hundreds of sessions and more.
Registration is now open.
Make plans to attend the Margaret Pfrommer Memorial Lecture in Long-term Mechanical Ventilation Monday, October 30, at 1:30 pm Convention Center, Room 701A.
"When Air becomes BREATH ... and a Life worth Living" is the title of the 2017 lecture to be presented by Audrey J. King, a Toronto native and a dedicated and effective advocate. King is ventilator user due to childhood polio and her efforts over the years has been a quest for independence for herself and for other ventilator users.
JIVD/ERCA Conference in 2018
First announcement: JIVD (Journes Internationales de Ventilation Domicile) and ERCA (European Respiratory Care Association) are working on the organization of their third joint meeting that will take place in Lyon, France, March 15 - 17, 2018.
FOCUS Spring 2018
May 4, 2018, Friday, Graceland Guesthouse, Memphis, Tennessee. Watch for details.
CCHS Family Conference 2018, alongside The 5th International CCHS Conference
June 19-23, 2018 at The Chase Park Plaza, St. Louis, Missouri, USA.
Philips Respironics is providing new software for the CoughAssist
As a direct result of the feedback and experience of their global clinician network, the CoughAssist T70 now comes with a set of new functionalities, such as:
The CoughAssist T70 mobilizes and loosens secretions by providing high frequency oscillatory vibrations while gradually applying a positive pressure to the airway, then rapidly shifting to a negative pressure. Adjustable oscillation levels enhance mobilization and increase the benefits of therapy.
Advanced Auto Mode
The Advanced Auto Mode allows the clinician to set a number of successive insufflations (pre-therapy breaths) prior to the cough therapy; this therapy pattern can be repeated up to 10 times as defined by the number of cycles. The clinician also has the option to end the sequence on a single insufflation by enabling the `Post-Therapy Breath’ setting. Advanced Auto Mode can help enhance recruitment as part of the airway clearance therapy and is suitable for use with all CoughAssist T70 patients.
The CoughAssist sold internationally is the E70. The E70 software is delayed on the website because it has not been released in some places. It will be completed in the next couple of weeks.
Ventilator company started by Dr. Forrest Bird to move
Percussionaire, a company started by the late Dr. Forrest Bird, will move into part of the old Coldwater Creek campus in Sandpoint, Idaho.
Percussionaire makes ventilators, including products used for patients in intensive care and people with advanced lung disease. Both manufacturing operations and the research and development team (about 50 employees) will be housed in the building. The move should be complete by mid-summer.
Bird, a physician, aviator and inventor, died at age 94 in 2015. He created the first low-cost, mass-produced medical respirators, including the “Babybird” in 1970 that replaced the iron lung and dramatically reduced infant mortality.