As the United States continues to battle increasing cases of COVID-19, global efforts to fight the virus continues to unite manufacturers and medical personnel worldwide.
A CPAP hood that got its start in Italy in 2001 has received the FDA Emergency Use Authorization (EUA) approval for its use in hospitals in the United States.
It was a long – and perhaps sometimes bumpy – road to obtain these approvals, but all worth it in the end, according to Marco Finotti, Critical Care Product Manager at Intersurgical Complete Respiratory Systems, a UK-based company.
Intersurgical developed the first helmet in 2001 as the available CPAP masks were exceedingly difficult to maintain the seal and uncomfortable for patients.
“Italian physicians were looking to solutions to improve the CPAP quality for their patients in the ICU … They reached out to the small company StarMed … So together, with them, we designed the first CPAP hood,” Finotti said.
The hood was connected to free flow gases, high flow blenders, and venturi flow drivers. Working with clinicians, they determined what components worked best for the patient and improved the efficacy of CPAP. Meantime from about 2002 to about 2005 clinical studies highlighting the advantages of the interface as well as important technical aspects, helped determine the best use of the new concept product. One example above all was the definition of the minimum flow needed to washout the patient’s expired CO2 from the hood.
“Then we were quickly requested to extend the benefits of the hood interface (which are the comfort for the patient, the ability to start the treatment very early and continue for many hours if needed) to the mechanical ventilator,” Finotti said.
The question arose: Could the same concept be used for mechanical ventilation in Pressure Support or Bipap ventilation modes?
While the basic concept was still applicable, it needed to be tweaked. So, once again working with physicians, they developed a new family of hoods, designed specifically for the purpose of mechanical ventilation.
“We learned, step-by-step, that the volume has to be reduced, the compliance of the system has to be reduced, and many other inputs led us to design an optimized hood for ventilation,” Finotti said.
The company's Research and Development Team continues to develop new helmet models and accessories to improve hoods that can be used for different medical situations. This includes hoods for CPAP and hoods for use on the mechanical ventilator, “openable” hoods, and hoods with no rigid ring... The challenge was which hood should be presented to the FDA for emergency use authorization.
“We did choose the NIV hood for the very simple reason that it’s a smaller design, but if it has to be used for CPAP, when it’s compared to a normal face mask, still has all the benefits of the hood interface compared to masks,” Finotti said.
StarMed NIV is somewhat of a multi-use helmet, depending on the need of the patient and the clinician. It has some specific differences.
“We are very proud of the material used for the neck seal: we really believe this is one of the big differences between our product and the others,” Finotti said.
The material is an extremely thin, plastic film that is not silicon, but exceptionally soft and elastic. It also has biocompatibility that is optimal and is a better material for the application for which it is used. The neck seal has been improved not only for the patients’ compliance but for safety. The hood has an inflatable neck cushion that improves the patient’s comfort and helps to stabilize the interface to achieve optimal mechanical performance. As a result, many clinical studies have proven the effectiveness and great performance of NIV hoods in different patient populations.
Even before COVID-19 emerged, the company was working on different helmets and added some improvements that alone took a few months to complete. The flow diffusers were redesigned to generate less noise and improve flow dynamics, the access ports for feeding tubes and catheters were shaped for ensuring optimal seal on various lumen gauges. Two color-coded caps are provided for these accesses to cover all possible catheter options needed for patients of different sizes.
“It’s an easy system to apply after you get used to it,” Savickaite said. “We’re going to go through the learning curve here, but with an early application to the patient – on the field, in the ER, on the wards – we can definitely increase the survival rate for these patients and prevent all the complications that may come with the delay of positive pressure ventilation.”
Helmets can also be a huge benefit to immune-suppressed patients, she added.
Savickaite credited the Italian physicians for their work and research.
“I know that everybody is asking for more studies done in the US, but you can always look what the Italian physicians did, who spend so much time and have lots of experience with the helmet ventilation – and they are still using it, so that should be a good product, right?”
“In today’s new world, where we are getting used to the new normal, I think the helmet is a great device to prevent the pathogens to spread out and prepare us for more pandemics. The helmet ventilation can actually stop that spread – or at least reduce it,” Savickaite said.
About Intersurgical Complete Respiratory Systems:
Intersurgical is a global designer, manufacturer, and supplier of a wide range of medical devices for respiratory support. “We provide flexible patient solutions for airway management, anesthesia, critical care, and oxygen & aerosol therapy for use within emergency care, hospitals, and in the home."
You can send your inquiry directly to the manufacturer here
Hands-On Review Video - NIV StarMed CaStar R Hood from Intersurgical Ltd