The Augumented Infant Resuscitation: Refining a hackathon invention to reduce infant mortality at scale

By: Kevin Cedone, Dr. Santorino Data, Kristian Olson and Jim Wright.

Cross-posted on the Healthy Newborn blog on October 6, 2014.

 


Standard neonatal bag value mask (BVM) resuscitator. Photo: AIR Project

 

The Augmented Infant Resuscitator (AIR) is an add-on device for bag-valve-mask (BVM) resuscitators to improve emergency ventilation. It monitors manual ventilation to provide real-time feedback on ventilation technique/quality and common errors such as leakage between the face and mask, airway blockage and incorrect pace or volume.

The AIR device was co-invented by a team of doctors and engineers from the Massachusetts Institute of Technology (MIT), Massachusetts General Hospital (MGH) and Uganda’s Mbarara University of Science and Technology (MUST).

This diverse team did not meet in an academic lab, or work together at an existing medical device company. The team met by chance at a hackathon. Hackathons are short events, typically a day or two, where entrepreneurs, investors, engineers, designers, programmers, tinkerers, students, professionals and mentors gather to work together. They usually have a theme (e.g. global health, mobile payments, water, etc.) and a few keynote speakers to provide framing and context to the event. Typically, the event starts with several rounds of pitches where researchers can pitch new technology or methods, or industry people can pitch opportunities or recruit teammates for existing start-ups. Then the work starts. At the end of the event, the team’s progress is evaluated by a panel of judges, usually after a 3 minute elevator-pitch presentation and/or product demo.

The Consortium for Affordable Medical Technology (CAMTech) sponsored the Hacking Medicine hackathon hosted at Massachusetts General Hospital in October 2012 that brought the team together.

The hackathon attracted clinicians, engineers, designers, other stakeholders and experts. Their goal was to rapidly build prototype business models, apps or devices to improve global health.

One of the invited guests from MUST, a CAMTech affiliate in Uganda,Dr. Santorino Data described the issue of perinatal asphyxia. As a national trainer for Helping Babies Breathe (HBB) program he is responsible for training doctors, nurses and midwives in essential newborn care, including emergency ventilation.

Dr. Santorino Data demonstrating BVM resuscitation technique at a training in Mbarara, Uganda. Photo: AIR Project

Dr. Data noticed that although HBB reduced newborn mortality, trainees who successfully completed training sometimes failed to perform neonatal resuscitation in a timely or effective manner when in clinical situations. In order to diagnose the problem in more detail, Dr.Data originally requested a data-logging attachment for BVMs. This device would permit post-mortem analysis of resuscitation failures, and with a time-date stamp, whom was working so they could learn from this event and participate in refresher training.


Dr. Santorino Data making his pitch at the CAMTech Hackathon. Photo: AIR Project

 

Dr. Data’s brief elevator-pitch presentation attracted interest from Kristian Olson, an MGH internist and pediatrician and HBB Master Trainer, Kevin Cedrone, then a mechanical engineering graduate studying automotive combustion at MIT, and Craig Mielcarz, an electrical engineer. The team rapidly iterated on design concepts, with the medical team members providing physiological insight into the problem of perinatal asphyxia. During these first sessions, the concept evolved twice from the original data logger for post mortem analysis. The first was to provide live feedback to health workers during actual emergency ventilation in a clinical setting, not reserve it for analysis later. The sensors and technology required to log data are capable of providing real-time feedback. The second evolution was to add focus to resuscitation training, not just clinical practice. The AIR device can provide important feedback when trainees are first learning their resuscitation skills, so they are practicing and improving their hands-on technique from the moment they first use a bag-valve-mask resuscitator.

Using some scavenged medical hoses and surplus automotive sensors discarded form the automotive lab at MIT, Kevin and Craig built a working prototype overnight. The improvised unit proved that low-cost sensors could be integrated with a suitable algorithm to make a sophisticated and high-value judgment about the quality of ventilation. Moreover, as an add-on to, rather than replacement for existing BVMs, this tool could extend the range and impact of existing ventilation equipment without requiring replacement. This is especially critical in low-resource settings where funds for resuscitation equipment may be at a premium.

The team demonstrated the prototype to the judges with a graphical user interface (GUI) tethered to a laptop and won first place, best overall invention at the hackathon.

Simple GUI showing raw pressure and flow data. The background is colour-coded red when there is a significant problem, in this case a leak. Photo: AIR Project

 

Since then, the team continued to develop the device. The cost is lower by one order of magnitude, the sensitivity is higher and the device is smaller and consumes less power.

The size, shape and user interface are being refined based on user feedback. An updated prototype will be submitted for randomized control trials in the Boston area and Uganda to measure its quantitative accuracy, whether (and how much) the AIR device improves ventilation. These developments, and the results of field trials to assess feasibility and technology acceptance will be the subject of future blog posts.

The Saving Lives at Birth grant has been instrumental in our development. Among other things, the Saving Lives at Birth grant:

  1. It has provided essential resources for engineering, business development, and clinical evaluation. The SL@B grant allowed the team to hire a research assistant to gather and analyze experimental in Uganda.
     
  2. Advocacy by the GCC Program staff has elevated visibility of the AIR device. The SL@B project manager with Grand Challenges Canada has given us several valuable introductions during regular progress meetings.
     
  3. The introductions to key personnel and legitimacy that the SLAB award offers is beginning to open avenues for potential scale. The seed grant came at a critical time when the crude, but working proof-of-concept prototype needed time and money for refinement.

 

 

The Saving Lives at Birth Grand Challenge calls on the brightest minds across the globe to identify and scale up transformative prevention and treatment approaches for pregnant women and newborns around the time of birth. This is the third installment of the Healthy Newborn Network's series profiling several innovations from this year's DevelopmentXchange.