RESPAP - Bubble CPAP oxygen therapy for children with Pneumonia and respiratory distress conditions

Respiratory illness is one of the major reasons for deaths globally. 1 in 6 die due to respiratory illnesses. Pneumonia claims the life of a child every 20 seconds. In India as in many other low- and middle income countries pneumonia and other acute lower respiratory infections are the most common causes of serious illness and death.  

Pneumonia is currently the leading cause of death among children worldwideand India has a huge burden of childhood pneumonia than any other countryaccounting for 20 percentage of deaths worldwide from the disease.  

Hypoxemia is the greatestrisk factor for pneumoniarelated mortality, and identification of hypoxemia  with pulse oximetry and administration of oxygen therapy can significantly reduce pneumoniarelated mortality. However, despite the provision of oxygen, antibiotics, and  supportive care, casefatality rates for severe pneumonia and hypoxemia are high in many hospitals in developing countries.

ResPAP is a medical device developed by Biodesign Innovation Labs that works on the principle of Bubble Continuous positive airway pressure (BCPAP) as an oxygen therapy solution for children under 5 years of age suffering from Pneumonia and other respiratory distress conditions. 

It is a novel, indigenous, innovative and easy to use device developed for resource poor healthcare settings for treatment of children with respiratory illnesses. 

The ResPAP consists of an Air Flow Unit , a pressure generator  and a nasal
interface . When assembled together the, nasal interface (a High Flow Nasal Cannula) is attached to the patients’ nares and one end of the AFU is connected to the Air/Oxygen supply. Gas passes through the AFU to the nasal prong and to the patient. The clinician can provide non-invasive positive pressure ventilation, by regulating the gas flow to the circuit and the magnitude of the positive pressure can be controlled by adjusting the regulator in the PAP valve.

Bubble-CPAP treats hypoxaemic and hypercarbic respiratory failure by expanding lungs towards optimal functional residual capacity, improves gas exchange and work of breathing by optimising ventilation/perfusion matching, improving lung compliance and reducing airway resistance. When
ventilators or CPAP machines are unavailable, doctors attempt to make frugal bCPAPs. This involves cutting and modifying normal nasal prongs and taping it to baby’s face, submerging the ends of nasal tube in water-filled plastic bottles and connecting other end to oxygen cylinders or concentrators.
Current WHO policy suggests the use of such setups during the unavailability of a ventilator or CPAP machine.
ResPAP kit is a solution that aims in replacing frugal bCPAPs with an innovative standardised airway-circuit that is easy to deploy and use, yet affordable to low-resource settings, working with minimal infrastructure. 

The ResPAP kit enables clinicians to provide reliable and affordable bubble
CPAP without the need to resort to improvising on the ground, like WHOs suggestion.

Clinical studies publication : https://drive.google.com/file/...

Product video : 

Continuous positive airway pressure (CPAP) has been used in children with    bronchiolitis for a long time. Currently in the low resource settings, the method of providing oxygen therapy via bubble CPAP to children with respiratory distress is not standardized and the existing low flow oxygen therapy has a high mortality rate. In India as in many other low‐ and middle income countries pneumonia and other acute lower respiratory infections are the most common causes of serious illness and death. Pneumonia is currently the leading cause of death among children worldwide, and India has a huge burden of childhood pneumonia than any other country, accounting for 20% deaths worldwide from the disease.

Hypoxemia is the greatest risk factor for pneumonia related mortality, and identification of hypoxemia with pulse oximetry and administration of oxygen therapy can significantly reduce  pneumonia related mortality. However, despite the provision of oxygen, antibiotics, and supportive care, case fatality rates for severe pneumonia and hypoxemia are high in many hospitals in developing countries.

Our solution Respap serve the population of children under 5 years of age from 5 months to 58 months old. It helps with reducing treatment cost, easy to use for the paediatricians and healthcare staff for usage in the PICUs and resource poor healthcare settings where children need oxygen therapy due to the respiratory conditions due to Pneumonia, bronchiolitis and other respiratory conditions due to flu seasons etc. 

Populations in developing countries, underdeveloped countries could be benefited with this innovation and could impact positively millions of people through the solution. Low income families who are not able to afford the treatment for children under 5 years of age for treatment of Pneumonia and other respiratory conditions is the primary target demographic audience whose lives we are trying to impact through solution. 

Our team consists of Doctors, Engineers, Researchers, Designers, Public health professionals and other domain experts who are passionate about saving lives and improving quality of care for patients at a population level and create impact positively at scale for patients through innovation, technology and design thinking principles. Our team has a 40 plus years of experience combined who has diverse experience in medical, clinical, engineering and technology etc. Our team is best positioned to solve this problem at a global level, and we have already deployed our solutions across hospitals in India. 

We have built our market ready, Respap medical device which is a paediatric respiratory device that provides Bubble CPAP oxygen therapy for children under 5 years of age suffering from Pneumonia and other respiratory distress conditions. We have served over 1000 patients through our deployments. 

We have done clinical trials for RESPAP Bubble CPAP oxygen therapy solution at hospital in India for children under 5 years of age suffering from Pneumonia, bronchiolitis and other respiratory distress conditions at the Pediatric intensive care unit in a major hospital after getting the concerned IERB approval and other clearances and proved through our clinical studies that the innovative medical device Respap which we have developed has proven its efficacy, effectiveness, safety when compared to the other existing standard treatments available such as low flow oxygen therapy, high flow oxygen therapy and providing good results from our clinical studies. 

We have since then deployed our solutions across 50 plus hospitals across India which benefits families who are not able to afford the traditional treatment available in the market and we are able to provide accessible and affordable lifesaving solutions for patients and impact positively. However, we are still in the growth phase and needs to do a lot of work in scaling up across various parts of India and other countries through various channel partners, channels, multiple different programs etc. 

During COVID, we have deployed our solutions in many hospitals across India which helped thousands of patients. We have won awards, grants, competitions such as CISCO Global Problem Solver Challenge Pandemic Response Prize, Qualcomm Design India Challenge, CAMTech MGH Award, Elevate 100 Government of Karnataka Award, DST Nidhi Prayas Grant, DBT BIRAC BIG Grant, IIT Bombay Best Campus Startup Award, Halcyon Fellowship, Global Good Fund Fellowship, DST Nidhi4COVID Award, CCAMP Covid Fund, Northeastern University Gap Funding, George Mason University's Emergent Ventures award, Nasscom BIRAC Jancare Challenge, Ayushman Bharat PM Jay etc. 

To advance our solutions to different markets and help patients and amplify our impact at scale. We are also looking for collaborations for technology development, networking opportunities for investment, strategy, market access, distribution support and opportunities for funding for scaling our solutions and advice for business development, go to market and regulatory support. 

Bubble-CPAP treats hypoxaemic and hypercarbic respiratory failure by expanding lungs towards optimal functional residual capacity, improves gas exchange and work of breathing by optimising ventilation/perfusion matching, improving lung compliance and reducing airway resistance. When
ventilators or CPAP machines are unavailable, doctors attempt to make frugal bCPAPs. This involves cutting and modifying normal nasal prongs and taping it to baby’s face, submerging the ends of nasal tube in water-filled plastic bottles and connecting other end to oxygen cylinders or concentrators.
Current WHO policy suggests the use of such setups during the unavailability of a ventilator or CPAP machine. ResPAP kit is a solution that aims in replacing frugal bCPAPs with an innovative standardised airway-circuit that is easy to deploy and use, yet affordable to low-resource settings, working with
minimal infrastructure. The ResPAP kit enables clinicians to provide reliable and affordable bubble CPAP without the need to resort to improvising on the ground, like WHOs suggestion.

The design intent behind the circuit is: ‘to create a higher ambient pressure for the patient to inhale and exhale supplemental oxygen’. This requires a breathing circuit with a flow generator, PEEP generator and the nasal interface. The flow can be derived from the oxygen source and the pressure
can be developed by constricting this flow. This constricted flow has to be maintained in a chamber, which would be the source of gas at higher pressure relative to atmospheric pressure, in this case the gas is Oxygen or Air-Oxygen mixture. If a nasal interface is attached to this pressure chamber and positioned on the patients nares tightly, she could breathe at a higher ambient pressure, thus the system would be delivering CPAP. This pressure chamber could be integrated to the circuit itself, essentially making an Air Flow Unit (AFU). A nasal prong could be connected at a convenient length
in this AFU. The distal end of the AFU should be connected to a valve that offers resistance to flow. A water column offers the required pressure depending on the depth to which the gas outlet is submerged to.

An initial design was developed taking 25mm corrugated tubing generally used for anesthesia. Using readily available couplers and adaptors this AFU was assembled. The Positive pressure(PAP Valve) was created by using an off-the-shelf storage container the top of which was modified to provide a
snap lock fitting using silicone sleeve to adjust and regulate the depth of immersion of the expiratory tube.

Pneumonia is major cause for deaths in children under 5 years of age. There is a high mortality rate in developing countries despite the provision of antibiotics, oxygen therapy. The existing treatments include as low flow oxygen therapy, high flow nasal cannula. ResPAP is novel, indigenous, affordable, easy to use, medical device developed by Biodesign Innovation Labs that provides Bubble CPAP oxygen therapy for children from 5 months to 58 months suffering from Pneumonia and Hypoxaemia. We have clinical studies and pilots at hospitals across India which proves the efficacy, safety, effectiveness of our Respap Bubble CPAP for treatment of Pneumonia in children under five years of age compared to low flow oxygen therapy, high flow nasal cannula. 

Children U5 with pneumonia with respiratory distress, Bubble CPAP is more effective than standard low-flow oxygen therapy to reduce treatment failure 

Doctors in developing countries resort to create ‘Jugaad Frugal Methods’ like making use of Saline bottle/Shampoo bootle to provide bubble CPAP for children.

The ResPAP enables clinicians to provide standardized, reliable and affordable bubble CPAP without the need to resort to improvising on the ground. 

Providing Continuous Positive Airway Pressure 

• Lungs inflated

• Decrease the work of breathing 

• Reduces ventilation-perfusion mismatch. 

• Improves Hypoxaemia

Mode of action :

1. Increases functional residual capacity.

2. Reduces right to left shunting by reducing the ventilation:perfusion mismatch.

3. Decreases airway resistance by increasing pharyngeal cross-sectional area. 

4. Reduces obstructive apnoea.

5. Stabilises the respiratory rate.

6. Reduces the severity of central apnoea.

7. Protective effect on surfactant.

The ResPAP is available at a fraction of the cost, when compared to existing solutions and therefore, reducing treatment for people who cannot afford.

The ResPAP is a standardized solution that is highly reliable to keep the babies oxygenated during respiratory distress. 

The ResPAP will have all the essentials to provide CPAP, so the clinicians & nurses can easily deploy it to patient in a resource poor settings hospitals without referring to higher hospital  or at least stabilize for time being till the availability of a ventilator and therefore saving lives of children under 5 years.

Good health and well being in the sustainable development goals is the main impact goals. Our goal is to make life saving critical care, emergency care, respiratory care accessible and affordable to patients, improve clinical outcomes of patients, reduce treatment cost at a population level impacting millions of patients globally at a population level. 

The core technology that powers our solution is proprietary design, data processing algorithms, pneumatic, sensor based technologies, Bubble CPAP principle of back pressure PEEP. 

We about 6 team members who are full-time and three part-time.

We have been working on our solution since early 2017. 

Our team consists of diverse members from different backgrounds and cultures, ethnicities and gender. We have 50% of team consisting of women who have been with us since early days of our company contributing to the growth of our company. We have hired team members from remote areas to work on our mission to make healthcare accessible, affordable to all and also creating jobs for the lower income families and underrepresented communities.  

Our business model is the following:

We sell our medical equipments at a unit price which is a one time cost for the hospitals, government procurement agencies for hospitals, breathing circuit consumables which is a recurring cost for each patient and service cost for yearly basis. 

We sell the our medical equipments to hospitals, distributors, Government healthcare agencies, private companies, NGOs, foundations, emergency and ambulance service providers. 

We work with various channel partners to supply our medical equipments to reach end users and beneficiaries such as Doctor and patients respectively. 

We have worked with the Government of India at the central level, state level to access the hospitals through our pilots, clinical trials. We will work with the stakeholders to enable access to our Respiratory care devices to all the hospitals across India through the directorate of  healthcare and family, Ayushman bharat PM JAY, ICMR, AIIMS, Mission Director at central government and state government level to make our solutions accessible across India. We will also work with various distributors, NGOs, non-profits,