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Although the variety of noninvasive interfaces for pediatric patients has grown in the past 10 years, they are still limited. Pediatric interfaces are typically scaled down from adult to child sizes, which does not consider the contours of a growing child’s face, causing poor fit in patients of certain ages. Donald S. Prough, MD, FCCM, was joined by Natalie Napolitano, MPH, RRT-NPS, during the 2023 Critical Care Congress to discuss how clinicians’ need to have the right equipment for their patients led to a device development project using 3D imaging that obtained sample sizes from various age groups to bridge the fit gap and lessen pressure point injury among pediatric patients. Natalie Napolitano, MPH, RRT-NPS, is a respiratory therapist and research clinical specialist at the Children's Hospital of Philadelphia in Philadelphia, Pennsylvania, USA.
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Dr. Prough: Hello, and welcome to the 2023 Critical Care Congress edition of the Society of Critical Care Medicine Podcast. I’m your host, Donald Prough. Today, I’m joined by Natalie Napolitano, MPH, RRT-NPS, to discuss the pediatric intensive care unit and 3D imaging. Natalie is a respiratory therapist and research clinical specialist at the Children’s Hospital of Philadelphia in Philadelphia, Pennsylvania. Welcome, Ms. Napolitano. Before we start, do you have any disclosures to report?
Ms. Napolitano: Yes, I do. As a clinical researcher and respiratory therapist, I have research relationships with several companies, Dräger Medical, Timpel, Actuated Medical, VERO Biotech, Philips Respironics.
Dr. Prough: You’re working in an area that’s important to critical care practitioners, but one with which most will have little experience. We’re looking forward to having you share your experience. To begin, how did you get started with device development?
Ms. Napolitano: Predominantly out of anger and frustration in the clinical setting of not having what I need to be able to do my job effectively in pediatric critical care and predominantly in respiratory failure.
Dr. Prough: In device development, you usually start with an unmet need. What’s the unmet need that you’re working on?
Ms. Napolitano: A couple of projects that we have been working on is trying to develop, or help other people develop, noninvasive interfaces for pediatric patients. We have, over the last 10 years, gotten a much better variety of interfaces available, but we still have a gap between about the age of six to eight months of age until nine years of age where we do not have adequate interfaces available. When I say that, I mean we may have one mask that might fit a child, but our policies and procedures at most children’s hospitals is to rotate interfaces every four to six hours to offload pressure so we don’t have pressure injury. There is still a significant amount of pressure injury that is being reported for children who are being treated with noninvasive ventilation continuously for weeks to months.
Dr. Prough: What kind of pressure injury are you talking about?
Ms. Napolitano: Predominantly on the nasal bridge where the masks hit the nasal septum, along the top of the forehead where the main pressure points are for anchoring noninvasive ventilation onto the face. Predominantly, we have nasal masks and that’s what we’ll fit. Our preference would be to have a nasal mask and then to change the pressure points completely by using an occlusive nasal prong that would offload pressure and have absolutely nothing on top of the nasal bridge, nothing on top of the forehead, change where the straps are hitting on their cheeks at the base of their skull. These are all locations where we very frequently have pressure injury in pediatrics when we’re using noninvasive ventilation.
Dr. Prough: So you don’t have an ideal interface for children across a pretty broad age range. What’s the first step in trying to figure out how to get interfaces that would be effective?
Ms. Napolitano: Our first step was trying to jerry-rig whatever it is that we have to make it work and realizing our failures there. Over my course of time and leadership within respiratory therapy departments, I’ve been able to work with a lot of our industry partners. They constantly ask, what can they do better? I’m honest and I tell them exactly what they can be doing better with their interfaces and what they can be creating that we actually need, first, the things that they’re spending their money and time on that we really don’t need another of. I was able to get past, over a period of time, the salespeople and get to the research and development folks in these companies and actually bring some engineers to the bedside so they can see the challenges that we have and the reality when they’re standing in the ICU with you.
They see that 50% of your beds have children with noninvasive ventilation, and you go to the bedside and there’s four or five masks sitting there that we’ve tried that aren’t working, and we may use one for 20 to 30 minutes if that’s all that we can offload pressure on before they start to decompensate because the fit is not ideal. They see the need and they see a child struggling, and it makes them more willing to help. Our unmet need was not having what we needed to do our job, and we started to see interfaces that they made that were for their adult patients, and they just made them smaller, not realizing how the contours of the growing face change, and that was causing leaks and other pressure point injuries, that we were finding new pressure point injuries.
Dr. Prough: Is this where your 3D imaging approach comes in?
Ms. Napolitano: Yes. After trying to work with about four different companies to make appropriate-sized masks for our gaps and needs, we got to the same stopping point every time; what are the right sizes, what are the right shapes, what are the measurements that are needed? We don’t have the answers to those questions. I was able to get the internal support to work on an investigator-initiated study that was unfunded through my institution. Partnering with our 3D printing lab at CHOP in use of their 3D surface scanner and some engineering time to help out, where we are doing whole-head 3D imaging or surface scans, so it’s more of a picture. There’s no radiation involved in this.
The engineers in the CHAMP Lab are dumping the images into MIMIC software and being able to make a series of 28 measurements that I’ve redefined for them. With that, we will be able try to figure out what are our normalized mask sizes for children ages zero to nine years of age. We’ve set out age-stratified groups of three months up until one year, and then one year through nine years of age, and we’re doing five children in each age range that have normal facial structures. Then, we’ll have a second arm of our study looking at children who have craniofacial anomalies as they’re a completely separate challenge of being able to fit with noninvasive ventilation, as a vast majority of them have significant sleep apnea prior to getting any of their surgical repairs.
Dr. Prough: So you’re doing 3D imaging, which is distinct from 3D printing.
Ms. Napolitano: Yes. Our goal for this project is just to determine what are the sizes before you can even start 3D printing and making masks. Once we can figure out what those sizes are, we’ll be making these measurements open source to be able to work with the companies who have been willing to make the masks but just needed the size.
Dr. Prough: Where did the number five come from, five children with normal facial structure in each of a range of ages? Is that a statistical guess? Is it a practical number? Where did it come from?
Ms. Napolitano: It was more of a practical guess, being able to do an unfunded study and being able to recruit children into the study and being able to get it done within a reasonable amount of time. I’m working with physician colleagues within pulmonary, our plastic surgery clinic, critical care medicine, and neonatology, and I just asked, “What do you think a good number is that we could do for this?” And we picked five to start out to get us going. If we find that there is a significant variance between those five, we may need to go back and amend our IRB to expand those numbers and recruit more.
Dr. Prough: These are healthy volunteers or children in the ICU? Where do the faces come from?
Ms. Napolitano: Both. We’re recruiting healthy volunteers through staff at the hospital as well as looking through the intensive care units and on our pulmonary unit. We have to have children that have normal facial structures but nothing on their face that could obscure any of the measurements that we’re trying to take, so they can’t be on oxygen, they can’t be on noninvasive ventilation, they can’t have a nasal feeding tube in or an oral feeding tube in. It’s the sweet spot of time that we’re catching them when they don’t need any sort of respiratory or feeding support where we can get the image before they’re discharged.
Dr. Prough: Do you need institutional review board approval to do that kind of study?
Ms. Napolitano: Yes. We did submit this and had approval for exemption through our institutional review board. It is radiation-free. Although there is no benefit to the patient, the benefit to future children was great, so we just need to receive verbal consent from the parents. Oftentimes we’re able to call them to get that consent. We have a small grant through the Pennsylvania Pediatric Device Consortium to be able to offer a $10 Amazon gift card for the inconvenience, for letting us do that. We are storing an image of their child, and some people are a little wary of that, but those images are staying stored on the CHOP network in the research drives, which is as secure as our medical records are. Only the measurements in aggregate are ever going to be shared.
Dr. Prough: Let me ask you a question now that might be too expansive. We might need to break it up into little parts. You identified an unmet need and, in order to get started on the process, you did 3D imaging of faces of normal children, and you’re planning to do some children with craniofacial abnormalities later on. How do you get a product from there to market?
Ms. Napolitano: That’s an excellent question. That is the next phase of working on this. We have one more seven-year-old child that we need to get some images from to close out our normal facial structure arm of the study. Then once we have all the measurements that we think we need in sizes of the masks, we’ll publish that. We’ll make that data open source so it can be used by anyone. Then I’m going to go back to the context of all the different companies that we’re willing to help in the beginning and convince them to make it. That’s our goal, not to start developing masks ourselves as clinicians and selling them and starting that business. I don’t really want to be making and selling masks. I want to be using the right masks for the children we’re trying to treat. Our hope is, with the partnerships with industry that we’ve made over time, that we’ll be able to provide them with the information that they requested, that they say they need in order to do this, and they’ll be able to start making these interfaces for us.
Dr. Prough: What kind of steps might they have to go through?
Ms. Napolitano: They are going to have to go through some prototyping processes, probably starting with 3D printing before they start doing molding for larger sizes. We would be willing to partner with them to do the clinical trials and testing for a noninvasive interface to get approval through the FDA. It’s a class 2 device, so you don’t have to have clinical outcomes research in order to do that. It’s bench research. I do have a bench lab that we do a lot of bench testing with, so we’d be able to partner with them to do that bench research that they need if they don’t have the ability to do that internally. They have to go through a lot of testing on safety of the material and the processes as well. There’s a good amount of cost and risk for them at that point. Some of the companies that we’ve worked with are smaller companies that will be able to apply for SBIR grants to help with that process, as well as potentially through the Pediatric Device Consortium or one of the other FDA-funded consortiums that offer grants to help support this type of early-stage prototyping.
Dr. Prough: Some of our listeners may not be familiar with SBIR grants. What are they?
Ms. Napolitano: They’re small business innovation grants that help with the early-stage device development process for small companies. I’m not exactly sure what the guidelines are as to what makes you a small business for the FDA. But there are several different small prototyping companies out there that will work with SBIRs to get to a product, then they sell that off to the larger companies to do the broad distribution and marketing and production of the products.
Dr. Prough: Who was involved in your team working on the 3D imaging process?
Ms. Napolitano: Within my research team, I have a full-time research coordinator who is a respiratory therapist, and I have three other respiratory therapists who have done a small amount of time out of clinical, helping to recruit into this study and do the capture of the 3D imaging. I also have a biomedical engineer in our 3D printing lab who has been working on the images on the back end after we collect them. We were able to get a scholar biomedical engineering student to work over the summer to help get a lot of the measurements and help our biomedical engineer out to get some of this done a little bit quicker. There is also a statistician who works in the 3D printing lab that will help us with all of the data afterward that we’re collecting from the images to help create the sizes of the masks through statistical modeling that we’ll need in order to give that information to the companies and to publish that. Then, I have physician partners in all of the areas that we are recruiting through critical care medicine, neonatology, pulmonary, and plastic surgery, so that they’re working with their colleagues and letting us recruit through their patients in their areas.
Dr. Prough: That’s a big team. Again, to get from where you are now to where someone might have a marketable device, are there other team members that are necessary?
Ms. Napolitano: Industry is a huge partner. A lot of times within academic medicine, industry gets the scarlet letter. But they’re a big partner in trying to help to develop devices unless you’re wanting to go out on your own and you become industry. Working with them to be able to do a lot of the rapid prototyping and testing and being willing to go through the FDA process is really important. They’re an important piece of this.
Dr. Prough: Do you need business expertise at the stage you’re working at or does that come in later with the companies?
Ms. Napolitano: That’s a great question. I have to have a little bit of an understanding as to what they’re going to need to go through to help get them the information that they need. One of the common questions or conversations I had with industry leading up to them being even willing to make masks was that they thought that it was such a small market that it wasn’t worth going into, that there are not a lot of children that utilize noninvasive ventilation, and there wouldn’t need to be many masks, and this is something that they would need to at least break even on, if not make some money; they can’t be losing money making these masks. You have to understand that. We need the companies to be able to stay solvent, to keep making the product and selling the product. But because there is not a lot of literature on the use of invasive mechanical ventilation successes and failures, incidence data outside of small, single-center, single-disease studies, they can’t make a business case to their board of directors and the individuals to approve the new products that they’ll be making.
One of the other projects I’m working on is to help categorize the landscape of the use of noninvasive ventilation within a tertiary pediatric ICU at Children’s Hospital. For my PhD dissertation, I will be working on looking back at five years of data within my pediatric ICU that I work in at CHOP and categorizing the types of patients that we see on noninvasive ventilation, their ages, their weights, their race, their sizes, how long they’re on, their successes, and their failures. That will help with industry to make their business case, knowing that, over time, how often it’s being used. That project is going a step farther, looking at the differences between our successes and our failures and hopefully creating an age-normalized risk failure score for noninvasive ventilation, so that we can better predict when someone is failing to move to invasive ventilation quicker.
Dr. Prough: Are the noninvasive interfaces for adults acceptable?
Ms. Napolitano: No, they’re not. They’re too big. The headgear to keep the masks on the face are too large. The nasal prongs are definitely far too big for patients and the contours of the face of a growing child getting to adulthood change. The contour of the mask hits a child’s face differently even if it’s a small adult, which could be a large pediatric, it fits different pressure points where in an adult it would be an indentation in your face; for a child, it’s a large cheek, so it causes a bigger pressure point. We really need to have the masks fitting to the contours of a child’s face.
Dr. Prough: Do the interfaces work well in adults?
Ms. Napolitano: For the most part, they’re working well in adults and they have a lot of different options available, but they’re also using them for shorter time frames. There are a lot more adults with obstructive sleep apnea where they’re using these masks and interfaces only overnight, so they have a large gap in time during the day when they don’t have a mask on their face. My husband, for one, utilizes a mask and he prefers one that doesn’t even touch his nose. It goes over the mouth and hits the top of the nares. That’s not even a shape that we have available to us in pediatrics. Then again, adults can have a full face mask, and if they feel that they’re getting sick and that they’re going to vomit, they can take that mask off, they can alert somebody. Children can’t do that. So we have added safety risks when using full-face interfaces with the risk of vomiting and aspiration with children. So we need more nasal interfaces and more sizes.
Dr. Prough: You mentioned the Pennsylvania Pediatric Device Consortium. Could you tell us a little more about that?
Ms. Napolitano: Sure. The PPDC is one of, I believe, eight funded pediatric device consortia by the FDA. The FDA gives out large grants for five-year intervals. Any children’s hospital or any organization that would have the appropriate expertise needed can apply for these grants. Their role is to help spur development in pediatric devices, either initially something that is just for pediatrics or to appropriately resize devices from adults or neonates up into what is needed for children of all the ages in between. Pennsylvania’s Device Consortium is housed at the Children’s Hospital of Philadelphia, and I’m a co-I of that consortium. We have a large amount of money that allows us to be able to disseminate smaller $50,000 research grants yearly. We give about eight to 10 of them out a year for people who are looking to do device development; a lot of them are clinicians working in early stage; early-stage device development is very hard to get funded.
There aren’t a lot of grants out there. A lot of the smaller foundations and companies really want you to be at a later stage to know that they’re giving money to something that’s actually going to grow legs and do something. We also work with regulatory experts where people just need help going through the regulatory process once they have a device, as well as assistance with prototyping and design. So instead of giving a grant of money to help them continue on with their process or their testing, we may help them even at an earlier stage with design and development through prototyping companies and have all the contracts in place to help them protect their IP for that.
Dr. Prough: Does the device consortium only work with investigators in Pennsylvania or is it a national resource?
Ms. Napolitano: It’s a great question. They will work with people from all over the United States. You can apply for a grant to any pediatric device consortium. They’re widely dispersed around the United States. Generally, the resources they have are going to be more local. So if somebody applied from Wisconsin to the Pediatric Device Consortium and we felt that the best support that we could give them for that project would be prototyping resources, ours are local so it might not be the best for them. It’s probably likely the best to look toward your closest device consortium, of which they’re pretty widely dispersed. The closest here to us in San Francisco is CHLA.
Dr. Prough: Is there anything else you’d like our listeners to know about your 3D imaging project or the development of pediatric devices in general?
Ms. Napolitano: I think it’s important for people to understand there’s an extensive progression to try to do this. When I speak with a lot of our physicians in house, they ask why we haven’t done this yet, why is this taking so long? It takes a long time to go through the IRB, to recruit the patients, to get the information. Then, once it gets to the stage with an industry doing the early prototyping and the testing, it takes a lot more than just creating a smaller mask. I think all of us who are pediatric clinicians know, in so many aspects of our medical care, that children are not small adults. That also goes to the shape of the devices that we’re using for them and taking care to get those appropriate devices. Getting to the point of doing 3D printing and early prototyping, there’s a lot of regulation on using those devices on children long term. A lot of our regulation has not been edited to come to the current time with current technology. Speaking with your elected officials and ensuring where are the barriers and what they can do in helping to update the FDA code and the regulation as to what needs to be done so that we can do more individualized medicine for people, including prototyping and 3D printing within the ICU for something that child would need.
Dr. Prough: Thank you very much. I appreciate your discussion of a very interesting project and one that I think will be illuminating for a lot of our listeners. This concludes another edition of the Society of Critical Care Medicine Podcast. For the Society of Critical Care Medicine Podcast, I’m Don Prough.
Donald S. Prough, MD, FCCM, serves as the SCCM Podcast editor. He is the Rebecca Terry White Distinguished Professor and Chair of Anesthesiology at the University of Texas Medical Branch in Galveston, Texas, USA. Dr. Prough completed his undergraduate studies at Lafayette College Medical School at Penn State University College of Medicine, residency at the National Naval Medical Center, and fellowship training in critical care at the National Naval Medical Center and in cardiac anesthesiology at University of Alabama Birmingham. He has served on SCCM’s Council and is a scientific editor of Critical Care Medicine.
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