Journey of indigenous ICU ventilator development project

Indigenous ICU ventilator - Make in India

As COVID-19 continues its relentless march across the globe, India has seen a sharp rise in cases threatening to overwhelm our hospitals and push our healthcare systems beyond their limits. Four months ago, when a national survey sounded the alarm, saying there were only 47,000 ventilators in the country, with imports costly and difficult, several minds decided to come together. The national appeal to promote ‘Make in India’ had to come to fruition. Moreover, it was the need of the hour to develop ventilators to address this very shortage.

Covid-19 frontline warriors at ICU, Ruby Hall Clinic

Innovate2BeatCOVID Grand Challenge

In March 2020, the Marico Innovation Foundation (MIF) under the leadership of Dr. Raghunath Mashelkar, announced the #Innovate2BeatCOVID Grand Challenge. It was then that Nocca Robotics and IIT Kanpur reached out to me for assistance. The challenge — they wanted us to guide and mentor them as they took up the task of developing an ICU ventilator. As an intensivist, I myself was in the midst of preparing our ICU at Ruby Hall Clinic, Pune to brace for the impact of Covid-19 pandemic, but looked at this challenge as an opportunity that would not only address the ventilator shortage but one which could significantly and positively impact the Make in India endeavour. I strongly believe that every innovative idea starts from powerful inspiration, and it was this very inspiration that propelled me to mentor and supervise the team.

Noccarc V310 ventilator by Nocca Robotics

Ventilator functioning

Firstly, it is important to establish the functionality of ventilators and how they are poised to help in times of a respiratory crisis. At its core, a ventilator is a simple machine, blowing oxygen-rich air into a body and removing carbon dioxide–loaded exhalations. The challenge for the engineering team was to ensure that it does that job consistently, and can precisely measure the volume, pressure, and timing of the breaths passing through a patient. If the air pressure entering a patient’s lungs is too low, the lungs could partially collapse and oxygen levels could drop dangerously, and if it’s too high, it could turn fatal. To add to it, a COVID-infected lung is very delicate and has a dynamically changing status. This is where patient safety plays a huge role.

Dr. Sanjay Pathare, Medical Director along with Team ICU gratefully receiving two Noccarc V310 ventilators from Nocca Robotics team

Development & Testing

The speed with which the team developed this technology was incredible, but then came the next challenge of testing and validating this technology. After all, a patient’s life would be on the line and this ventilator would be the bridge between life and death. As a mentor, I oversaw every step of the process. Right from the concepts of fundamentals and functionality to conducting countless studies and endurance rests —every step was crucial. It successfully passed all stringent electrical safety, performance and calibration tests. Now, the most important aspect was having the ventilator tested in a clinical setting to ensure patient safety. During the 28-day study at our ICU, our team monitored the machine round-the-clock. In fact, there was a point of time when our fellow, Dr. Nipun Gupta volunteered to administer the ventilator on himself. We were quick to notice that the device enabled him to breathe comfortably for several hours. Thereafter, it was also tested on a couple of patients with critical lung infections making it clinically validated.

Dr. Prachee Sathe explains the working of the ventilator

Award

Sure, it’s been a journey of grit and perseverance. Three months of this collaborative work resulted in the development of the Noccarc V310, an ICU ventilator that emerged victorious amongst 1500 entries in the #Innovate2BeatCOVID Challenge. This ventilator project emerged as India’s top 3 innovative ‘Ventilators and Other Respiratory Solutions’ and was awarded.  It was indeed a moment of pride for us to see our efforts come to fruition! I am also honoured that Nocca Robotics donated two ventilators to our institute. This gesture by Nocca Robotics will help us in the taking on the enormous challenge of ever increasing influx of coronavirus patients.

Nikhil Kurule, CEO, Nocca Robotics hands over Letter of Appreciation along with two ventilators to Dr. Prachee Sathe and team at ICU, Ruby Hall Clinic Key features of Noccarc V310 ventilator

The Noccarc V310 is a turbine-based ventilator which consists of all modes required by doctors. In addition to being a state-of-the-art ICU ventilator for complex respiratory failure, it has some of the most unique features including the HFNC (high-flow nasal cannula), BiPAP (bilevel positive airway pressure) and CPAP (continuous positive airway pressure) modes. This machine has PRVC (pressure-regulated volume control) mode as well apart from offering both volume and pressure control. The most unique feature of this ventilator is that it comes with a UV chamber. When a virus-infected patient on a ventilator breathes out, he exhales air filled with virus loads, making it hazardous for all of us. The UV filter chamber kills the virus making it a safer environment.

Appreciation

Letter of Appreciation from Nocca Robotics

At a time when many indigenous ventilators are being rejected due to lack of clinical validation and feasibility, the fact that our team has been part of a project that has seen the light of the day is indeed heartwarming. As a doctor, it makes me beam with pride that we managed to create synergy between our desire to provide wholehearted care in times of crisis along with fostering the spirit of local innovation - that too, when we are managing the onslaught of the COVID crisis. As a human being, it gives me hope that there will indeed be a brighter COVID-free tomorrow.

Letter of Appreciation from IIT Kanpur

Gratitude

My sincere gratitude to Nocca Robotics and IIT Kanpur for the opportunity to be part of this project and the faith they reposed in us. I would like to specifically thank the following :

• Dr. Amitabh Bandopadhyay, KENT Entrepreneurship & Innovation Chair Professor, IIT Kanpur
• Dr. Abhay Karandikar, Director, IIT Kanpur
• Mr. Rakesh Bhargava, Former Chairman, FK Oncology Ltd.
• Mr. Nikhil Kurule, Co-founder & CEO, Nocca Robotics Pvt. Ltd.
• Mr. Tushar Agarwal, Sr. Product Manager, Nocca Robotics Pvt. Ltd.
• Ms. Aditi Kumar, Technical & Operations Head, Bioprograms SIIC, IIT Kanpur
• Dr. Tanima Baronia, Sr. Consultant in-charge, ICU, Ruby Hall Clinic
• Dr. Sandhya Zambare, Intensivist, ICU, Ruby Hall Clinic
• Dr. Arun Kumar P, Jr. Consultant, ICU, Ruby Hall Clinic
• Dr T R Jadhav , ICU senior consultant 
• Dr. Nipun Gupta, Fellow DNB Critical Care, ICU, Ruby Hall Clinic
• Brother Dinesh Divakar, Brother in-charge, ICU Ruby Hall Clinic
• Sister Urmila Nalawade, Sister in-charge, ICU, Ruby Hall Clinic
• Mr. Mahesh Bhosale, Biomedical Engineer, Ruby Hall Clinic
• Mr. Bomi Bhote, CEO, Ruby Hall Clinic
• Dr. Purvez Grant, Managing Trustee, Ruby Hall Clinic

Ruby Hall Clinic, Pune

Unique Dussehra celebration at ICU

Dussehra Pooja

One of my favourite yearly events in the ICU goes like this. It has been a great tradition to worship the instruments and equipment in the ICU on the occasion of Dusshera like Shastra Pujan (शस्त्र पूजन).

Dr. Sharad Yadav performing Dussehra pooja with ICU team

While we perform rituals to honour our equipment and apparatus which is used for extending our professional services to our patients , we pray, may our means and efforts be honest, pure and with up to date functionality and knowledge when we treat our patients ! 

For ICU it is not a holiday but celebration of our work ethics. Even though it was COVID times, Dusshera 2020 was not an exception, having pooja with "all precautions".

Dnyan (ज्ञान) - Initiation on the path to Knowledge

Many of our staff were away from families and home for months on end since COVID started. Physical distance from the families could not stop us from being a great big family working day in and day out in critical care areas. On the day of Dusshera there was a surprise waiting for me in my office.

A small bright child of two and a half years, waiting for  something very important to happen in his life.

"Dnyan (ज्ञान)" (son of Dinesh,  nursing incharge of our ICU, who hails from Kerala),  was eagerly waiting for his Vidyarambham (विद्यारंभम) ! 

I was so touched to be with him and his parents, to hold his tiny hand and write in rice grains his first letters "Shri Ganeshay Namah (श्री गणेशाय नमः)" ! I was full of joy to initiate him on his path of exploration of Dnyan (ज्ञान).

Gift of Saraswati (सरस्वती)

There was an unexpected gift on my way from a dear friend Manju, depicting "Saraswati (सरस्वती)". It was done beautifully ! 

New normal begins

We all were reviewing the situation of CORONA in last few days, realising the regressing curve in Pune, Maharashtra and India. Hospitals were closing COVID wards. Ultimately  our ICU had some vacant beds after the tumultuous six months !!  It was a great moment to announce with great deliberation that we are going to close one of the COVID ICUs, to restart non covid aka "normal" ICU!  Everyone rejoiced .

Of Course, we should not let the guard down. The last thing we want is a second wave.

Be aware, be safe !

Artificial Ventilation - science and myths

Artificial Ventilation: Science and Myths

In dire need of the truth to be told about life-saving machines

Dr. Prachee sathe M.D., FRCP, FCCCM

Director, ICU, Ruby Hall Clinic, Pune, India

HISTORY

Hospital staff are examining a patient in a tank respirator, iron lung, during the Rhode Island polio epidemic. The iron lung encased the thoracic cavity externally in an air-tight chamber. The chamber was used to create a negative pressure around the thoracic cavity, thereby causing air to rush into the lungs to equalize intrapulmonary pressure. (1960) source : CDC

History is proof to the fact that major healthcare emergencies can call for creative solutions and that these can often be unorthodox. Take for example, the 1952 Copenhagen polio epidemic where over 300 patients developed respiratory paralysis within a short span of a few weeks with infectious hospitals being completely overwhelmed. Desperate times called for desperate measures. Relays of medical students manually ventilated the lungs of patients using rubber bags attached to tracheostomies under the guidance of the anaesthetist. 

In another case, in Beijing in 2003, trainees from unrelated specialties found themselves managing a sealed intensive therapy unit filled with avian flu victims, while receiving clinical guidance from overseas experts via a mobile phone.

Introduction

Modern day ventilator, a life saver

For someone who is drowning in the furious sea, a small boat can probably save his life. But this can be true only till the sea storm settles or the victim reaches a safe land. The boat will not settle the sea storm, but will probably provide enough support to save a person from a catastrophe. In reality, the ventilator can be compared to the small boat. Contrarily, artificial ventilation has been misunderstood over the years despite saving lives owing to wrong projections and misguided perceptions. There is a substantial misunderstanding about the complexities of intensive care treatments, especially life support interventions. 

At a time when the world is facing one of the most heart wrenching medical emergencies in the form of the novel coronavirus, the use of the ventilator has emerged to be the most successful method to save a dying life. In addition to lockdowns, curfews and economic upheaval, living-room discussions are revolving around the shortage of ventilators world over. Every country across the globe is busy assessing the available stock of working ventilators — much like assessing military equipment before starting a war.

With a population of 1.3 billion people, India has about 40,000 working ventilators in the private and public sector. According to global trends, about one in six people with Covid-19 gets seriously ill, which can include breathing difficulties. The country faces seeing its hospitals hobbled as others around the world have been, with doctors forced to choose who they try to save. The race to develop an inexpensive, home-grown invasive breathing machine seems to have begun and the government needs to be applauded for encouraging this initiative. 

What is a ventilator?

Is it a life saver? Is it a ‘money churning machine’ as mentioned by interlocutor and host Aamir Khan in Satyameva Jayate years ago? Or is it a machine for prolonging the meaningless and futile existence of human life? A ventilator is a hospital bedside machine that assists with two critical functions: getting enough oxygen into the bloodstream and clearing out carbon dioxide, which can build up when the patient is too weak or sick to move air in and out of the lungs. This allows the patient who has a respiratory condition to receive the proper amount of oxygen by creating a positive pressure. It also helps the patient’s body to heal, since it eliminates the extra energy of laboured breathing.

As intensivists, we use artificial ventilators as powerful tools and vital allies to manage patients with respiratory distress. The truth is that ventilators are not a cure or treatment by themselves. They merely act as a support system to buy time while the physiological aspects of the body can be medically managed, giving a patient’s lungs the much required time they need to heal by themselves. Having said this, there is much ambiguity about these life-saving machines and in times such as these, it’s perhaps best to clear the air about it.

Multiple machines in ICU for treatment of organ failure

What are some myths and facts related to the ventilator?

Myth: Once a patient is on the ventilator, he/she will not survive

Fact: When the human body is severely diseased or under stress, the lungs and heart need maximum support. This is a time when physiological processes in the body are very complex, fine-tuned and closely controlled. Herein, artificial ventilation comes into play. The fact is that when patients are provided support in the form of a ventilator, 75%-85% of them survive and go on to lead meaningful healthy lives even after prolonged ventilation.

Myth: Ventilators merely prolong a dying patient’s life

Fact: The truth is that every disease has a reversible and irreversible state. There is always a window of reversibility in any disease. This depends on the combined application of the experience of the intensivist and the ability of the machine help the patient recover in the long run, if the ventilator is used within optimum time.

Myth: Doctors use ventilators as per their will

Fact: There are certain scientific parameters that are crucial factors to utilising a ventilator for a patient hanging between life and death. This decision is always taken in conjunction with the will of the family and scientific factors. 

Monitoring of health parameters of patients in ICU

Myth: Once a patient is on the ventilator, the doctor has no specific role

Fact: A large number of medical workers are required when a patient is put on the ventilator. The patient is constantly manned by an army of people including senior intensivits, resident doctors, and   medical consultants who work round-the-clock. Right from what percentage of oxygen needs to be delivered, how may breaths per minute, how to remove carbon dioxide from the body, how not to cause any damage to the patient’s lungs - they find solutions to all these medical issues. 

Nurses too play an important role of supporting the patient and the family psychologically. Lab technicians and diagnostic imaging specialists too play their part in the everyday happenings. A team of physiotherapists ensure the muscles of patients don’t disfunction when he/she is weaned off it, while support staff take care of all the bedside needs of the patient including personal hygiene as well as changing the position of a patient. 

Myth: Being on ventilation equals to putting your life at risk.

Fact: The main risk of ventilation is an infection, as the artificial airway (breathing tube) may allow germs to enter the lung. When positive pressure ventilation is used as against the natural negative pressure ventilation, it is bound to have some side effects on the patient’s physiology. It transmits pressure on the heart making it function against resistance. In some cases, it may cause a drop in blood pressure and may cause heart to work even harder. In some cases, it could also increase blood pressure inside the lungs. However, that’s what we as intensivists work round-the-clock to prevent.

Myth: Once on ventilator, the hospital will keep the patient on it for a long time

Fact:

The main purpose of a ventilator is to allow the patient time to heal.

Usually, as soon as a patient can breathe effectively on their own, he/she is taken off the ventilator. Doctors perform a series of tests to check the patient's ability to breathe on their own. The healthcare firmament today is fighting one of its biggest battles of modern times, the roots of which seem to run far and wide across the length and breadth of the world. As doctors, and as part of our emergency management planning, we’re all exploring how we can do things which would not be our typical care. But in atypical times, we need to come up with creative and innovative solutions to do what we do best — save lives.

Covid-19 home isolation guide

Home isolation : when and how?

Situation at Pune

In Pune we are almost on the peak of the severe wave of pandemic covid-19. We are just waiting for it to get over but we do not know how long it will take. There are new cases being reported everyday and Pune has unfortunately reached number one slot  in India.

Post Lockdown

Lockdown has been relaxed but we need to keep restraint on our own behaviour. We should not go out like everything is normal. Social distancing, wearing proper masks, getting out only and only if it is required, protecting our elderly people are still the norms and we must follow these in letter and in spirit. The health care system, hospitals, health care workers are under tremendous pressure.  There have been unfortunate events of loss of life due to lack of bed, lack of ventilator or lack of oxygen. To avoid such situations, it is a primary responsibility of every citizen in and around Pune and in Maharashtra to follow the rules and protect ourselves and our family members.  Very very strictly we should abide by the rules.

What are we supposed to do if the test is to be taken ?

It may so happen  that one of us would develop mild symptoms like a day of fever, sore throat, irritation or severe pain in the body with feeling of weakness, which can be a premonition of developing Covid-19 disease. These symptoms should not be neglected. Do report and ask for medical assistance, if you have any of these symptoms. There are flu OPDs being run in the hospitals.

If you give the throat swab sample , please quarantine yourself immediately . Report will come to you on mail. Fortunately with telemedicine now a reality, there are multiple ways by which your doctor can help you . Please do not hide the symptoms. Number of people are coming forward voluntarily to undergo the test when there is an index case in the vicinity.  The close contacts are asked to quarantine themselves and test if they have any minimal symptoms or if it is a significant contact, to test themselves then and there.

Covid-19 test and protocol for home isolation

If you do a swab test, what will happen ? Either you will be negative or you will be positive...   if you are negative well and good, but remember that 30% can be false negative..  Hence based on your own judgement and the symptoms, do not get into a denial, but quarantaine yourself which is most important to prevent the spread of the disease in the community. If at all you are positive, Pune Municipal Corporation (PMC) has given a mandate to allow home isolation for asymptomatic or mild cases . This reduces the pressure on the hospital system as beds are in short supply. You can be at home under the supervision of medical team. If you are getting into home isolation, you must stay in a single room with attached bathroom and should not get into contact with anybody else in the family for 17 days which is the mandatory period. During this period, you should eat well, look after yourself, take good rest, take medicines that have been prescribed and drink a lot of liquids to keep yourself well hydrated.  You can even do small exercises within the room. In fact the self-monitoring you must do includes your oxygen levels. The pulse oximeter reading should be above 95% as far as possible. If it starts going below 93%, you should alert the medical team. You can do a 6 minutes walking test.  If oxygen saturation after exercise is falling, it gives a warning signal that you need to be investigated.  If cough is persistent or if there is a feeling of breathlessness, the doctor may ask you to do certain blood tests or CT scan of the thorax. These two things are important for stratification of your disease state. We should not miss the boat if at all required you may be asked to get hospitalised. If hospitalization is required, you may be needed to be given injectable antiviral and steroid which has proven itself  for supportive medication. The use of medications is totally at the discretion of the medical person who is attending to you during this period.

Dealing with children

There is a problem with young children, if the mother comes positive and the child is negative. In such a situation, other members in the family should take charge of the child.  If the child is positive and the mother is negative, then the mother should wear a  mask herself while taking care of the child. If there are multiple people at home who are positive, they can stay together or mingle together or work together at home . But positive and negative people should not mix while at home . 

17 days is not too long a period from the point of view of smooth recovery and prevention of spread of infection in the society. Accept this and take full care of yourself and family.

 

During this period there could be mental stress that bothers you , you  may feel claustrophobic,  you may  get negative thoughts or you may get overburdened by your work from home status. In such situations, please maintain cool and calm down. Please try to maintain a certain routine. If you are working from home, please make it a habit that you get ready like you are going to office and start working. This way, adhering to your routine will help you to maintain sanity. 

You may feel too stressed out some time. In such a situation, do not hesitate to communicate with your friends and supporters to share positive thoughts and positive energy. If it goes beyond that, you  may need any further support. Please feel free to talk to a psychologist and psychiatrist.

Cheer up and follow the rules, this is going to get over sooner than later as the vaccine is just around the corner. However, till that  time, do not get scared but take utmost precautions. It is  heartening to learn  that in India our survival rate is quite high. The mortality rate is below 2 %. The rate of patients getting better has reached approximately 70% in India.

We look forward to the day when this pandemic gets over. Till then, follow the rules. 

Make sure that you DO NOT get infected.

Basic clinical needs for ventilation of COVID-19 patients

Clinical needs for a ventilator for COVID-19 patient

This video titled "Basic clinical needs for a ventilator to ventilate a COVID 19 patient" is an introductory video , intended to help biomedical entrepreneurs to understand the the basic requirements to create a ventilatory machine to handle ARDS / difficult lung /in COVID19. For doctors who want to learn how to ventilate, there are other modules.

Need is the mother of Invention, when it comes to ventilators

Pandemics are testing times. Great to see Indian Govt taking charge of the situation so proactively at various levels of this disaster management. In response to the facts like shortcomings of health infra , scarcity of the life saving ventilators, big business houses, innovators , biomedical engineers, medicos are all trying to stand up to the situation. Hopefully it should see some significant developments in Indian scenario of critical care medicine for availability ,cost effectiveness and capacity building.

While it is absolutely true that the ventilators evolved from iron lungs to synchronised lung protective machines, it happened only with better and better understanding of the pathophysiology of diseased lungs prompting mechanical changes in the ventilators over the years. Many intensivists are facing the queries regarding new prototypes of ventilators coming up, how much ever the efforts are lauded , haste in making crude prototypes should not cause harm than help to tide over the crisis.

Video to encourage Make in India

Here is a video created in line with the specifications given by Govt of India for ventilators as an effort to explain the details to courageous groups coming forward to “Make in India” ! This video was created with encouragement from Dr L S Shashidhara, Professor and Dean (Research), Ashoka University, Sonipat, 131029 India and Professor, Indian Institute of Science Education and Research (IISER) Pune (Currently, on Lien at Ashoka University) The video was shot at the ICU at Ruby Hall Clinic and features the following intensivists - Dr. Prachee Sathe (Director, ICU), Dr. Tanima Baronia (Senior Consultant, In charge, ICU) and Dr. Arunkumar (Consultant)

Cost effectiveness is a great determinant of acceptance of treatment modality in our country and obviously of the outcomes. But when it comes to lifesaving treatments like artificial ventilators, imported from other countries, it becomes disproportionately high expenditure in the bill of a critically ill patient ,who so ever bears it. It can be very painful for a sensitive intensivist to explain the “COST” of life to patient family.

Life after COVID-19

The life is not going to be the same after COVID-19 and Critical Care Medicine and ICUs also are hopefully going to change for the better for the common man! Let us welcome the new developments, with concern for quality at the same time !

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