Creative and Inexpensive Solution for Ventilator Shortages

Creative and Inexpensive Solution for Ventilator Shortages
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“Mechanical ventilation is the main supportive treatment for critically ill patients” infected with novel coronavirus 2019 (COVID-19), according to a February 2020 study published in The Lancet Respiratory Medicine.1

But severe shortages of these life-saving machines have become a common concern echoed by hospitals across the U.S., with medical professionals and government officials alike calling for increased production of this critical resource.

Ventilators help people breathe when they can’t do it on their own. Sometimes referred to as “breathing machines,” ventilators help pump oxygen into your body and carbon dioxide out via a tube that goes into your mouth and windpipe in a process called intubation. The ventilator may automatically take a set number of “breaths” each minute or be programmed to kick in if you don’t take a breath in a predetermined amount of time.2

Either way, the machines are crucial for helping some patients survive until their lungs begin working on their own. In the case of COVID-19, it may lead to inflammation in your airways or fluid in your lungs, requiring mechanical ventilation to pump oxygen into your body. By some estimates, has many as 25% of people with COVID-19 become critically ill, and may need a ventilator to help them breathe.3

If ventilator shortages continue, and the number of people who need them at one time increase, doctors may be faced with making unthinkable choices about who gets to live or die based on who gets the ventilator and who does not. Creative solutions have emerged that may help, however, including the use of a converted snorkeling mask and converting ventilators to service more than one patient at a time.

Emergency Ventilator Mask Made From Snorkeling Mask

Isinnova, an Italian 3D printing company, was contacted by Dr. Renato Favero, a former head physician of the Gardone Valtrompia Hospital, with an idea to overcome the shortage of hospital Continuous positive airway pressure, or CPAP, masks for sub-intensive therapy.4

Isinnova has previously used 3D printing to make ventilator valves for local hospitals, leading Favero to seek them out for a plan to create an emergency ventilator mask by modifying a snorkeling mask already on the market.

While full ventilators breathe both in and out for a patient, CPAP machines, which are often used to treat severe sleep apnea, regulate the pressure and level of oxygen that reaches the lungs, using mild air pressure to keep breathing airways open.

According to the National Heart, Lung, and Blood Institute, the treatment “involves using a CPAP machine that includes a mask or other device that fits over your nose or your nose and mouth, straps to position the mask, a tube that connects the mask to the machine’s motor, and a motor that blows air into the tube.”5

Isinnova contacted Decathlon, the producer of the snorkeling Easybreath mask, and was able to create the emergency mask in just three days. “We had to do it very quickly because it was a matter of saving lives,” Isinnova engineer Alessandro Romaioli told Fox News. “We didn’t do it as a usual project, where we would have had time to check it three, four times. We just had to do it as quick as we could.”6

Isinnova initially printed about 50 special valves that they call the “Charlotte valve” designed to guarantee the mask’s connection to the ventilator, and tested it out at the Chiari Hospital. Isinnova explained:7

“The prototype as a whole has been tested on one of our colleagues directly inside the Chiari Hospital, connected to the ventilator body, and has proven to be correctly working. The hospital itself was enthusiastic about the idea and decided to test the device on a patient in need. The testing was successful.”

3D Design Free for All to Access

Isinnova has posted the design for its patented Charlotte valve on its website, stating that they want it to be available to all hospitals in need of it.

“Health care facilities in difficulty will be able to purchase the Decathlon mask … and get in contact with 3d printers who could make the piece and provide it,” the company stated. “We clarify that our initiative is totally nonprofit; we will not obtain any royalties on the idea of the link, nor on the sales of Decathlon masks.”8

While neither the mask nor the valve link are certified, they are designed for use in health care facilities that are in need of emergency medical supplies. So far, they’ve received feedback from doctors stating that the redesigned masks have helped to save lives. Romaioli told Fox News:

“The feedback has all been positive, not because it’s the biggest therapy in the world, but because they can apply some therapy to people that they haven’t been able to help before. All hospitals are going to run out of breathing masks, biomedical or certified, but these homemade masks can treat some patients that they couldn’t before.”9

Converting Ventilators to Treat Multiple Patients

Typically, one ventilator is used to treat one patient, but in extreme times such as a pandemic, some clever doctors have figured out ways to modify them so they can treat more than one person at a time, potentially doubling, tripling or even quadrupling the number of lives they can save.

Data published in a pilot study in 2016 by doctors Greg Neyman and Charelene Irvin Babcock found that a single ventilator could quickly be modified, using readily available plastic tubing, to ventilate four simulated adults for a limited time — about 12 hours.10

The doctors concluded, “While further study is necessary, this pilot study suggests significant potential for the expanded use of a single ventilator during cases of disaster surge involving multiple casualties with respiratory failure.”11 Babcock, who is now an emergency medicine physician in Detroit, Michigan, explains how to use the technique in the video above.

She says she was able to create the four-way adapter in 15 minutes using supplies at her hospital. And though she says caution is warranted, since the technique has only been studied in simulated test lungs and animals, not in humans, “it’s probably better than nothing in dire circumstances.”12

In fact, while it hasn’t been tested in humans and is an “off-label use of the ventilator,” the Neyman/Babcock technique has been used in humans.

Emergency room doctor Kevin Menes used the technique in 2017, after a mass shooting in Las Vegas flooded the emergency room with critically injured patients and they ran out of ventilators. By matching up two people with similar lung sizes and capacity, he was able to save lives by converting single ventilators to work for more than one person.13

Since Babcock shared the video of how to do the technique, Dr. Saud Anwar, a pulmonologist with the Eastern Connecticut Health Network, put it to action at Manchester Memorial Hospital and tested it on four simulated lungs, with promising success.

“One can get four patients on a single ventilator but it has to be done in an extremely focused manner,” he told Connecticut Magazine. “The catch is that the four patients need to be of a similar size with similar illness and similar lung physiology.”14

Nine Patients on One Ventilator?

Another doctor, Dr. Alain Gauthier, an anesthetist at the Perth and Smiths Falls District Hospital in Ontario, was also inspired by Babcock’s how-to video. In about 10 minutes, he rigged one ventilator to treat nine people.15 The possibility of increasing ventilators’ capacity to treat multiple patients may not be fool proof, but it’s encouraging when many states are fearing shortages.

One potential concern is cross-contamination between patients, but filters on the machine may help with that.16 There’s also a question of how the method will fare among people who need to be ventilated for longer periods of time. Gregory Barefoot, a physician's assistant (PA) and former chief PA at the Trauma and Surgical Critical Care service in Columbia, South Carolina, told Vice:

“Some of the patients that are suffering from COVID-19 are having to be ventilated for over a week in many cases … Ideally, the patients that would be grouped together would be of similar disease pattern, body habitus and with similar premorbid health status … a mode of ventilation should fit the patient, not the other way around.

Each person will interact with a ventilator differently and it is hard to individualize care among four patients with one ventilator.”17

How Many Ventilators Are in the US?

A 2010 study surveyed 4,305 U.S. hospitals that accounted for 83.8% of U.S. intensive care unit hospital beds at that time. There were 52,118 mechanical ventilators owned by the hospitals, with researchers estimating that, overall, there are 62,188 full-feature mechanical ventilators owned by U.S. acute care hospitals.18

They also estimated that there are another 98,738 devices other than full-feature ventilators at U.S. hospitals, and noted wide variation in numbers of ventilators across states.

The New York Times, meanwhile, estimated the number of ventilators in U.S. hospitals to be 160,000, along with an additional 12,700 in the National Strategic Stockpile, which includes medical supplies held by the U.S. government for emergencies.19 The America Hospital Association, meanwhile, has suggested that up to 960,000 Americans may need ventilator support due to COVID-19.20

“The reality is there is absolutely not enough,” Andreas Wieland, the chief executive of Hamilton Medical in Switzerland, which manufacturers ventilators, told The New York Times. “We see that in Italy, we saw that in China, we see it in France and other countries. We could sell I don’t know how many.”21

US Knew About Ventilator Shortages

Ventilator manufacturers can’t keep up with the demand, and efforts are underway to ramp up supplies. Ford reached an agreement with GE Healthcare to reportedly build 50,000 units within 100 days and work up to producing 30,000 per month, but production isn’t slated to start until the week of April 20, 2020.22

GM has also announced plans to partner with Ventec Life Systems to increase production of ventilators, but the question remains as to why the U.S. wasn’t prepared with enough ventilators for a pandemic such as this.

In a 2009 planning report from the Department of Health and Human Services (DHHS), it was estimated that a severe influenza pandemic could infect 90 million people, sending almost 1.5 million to intensive care units with 750,000 people requiring mechanical ventilation.23

In a 2003 report from the U.S. Government Accountability Office, it was also noted that “few hospitals have adequate medical equipment, such as the ventilators that are often needed for respiratory infections such as SARS, to handle the large increases in the number of patients that may result.”24,25 The U.S. even tried to build more ventilators more than a decade ago, but failed. The Times reported:26

“The plan was to build a large fleet of inexpensive portable devices to deploy in a flu pandemic or another crisis. Money was budgeted. A federal contract was signed. Work got underway.

And then things suddenly veered off course. A multibillion-dollar maker of medical devices bought the small California company that had been hired to design the new machines. The project ultimately produced zero ventilators.

That failure delayed the development of an affordable ventilator by at least half a decade, depriving hospitals, states and the federal government of the ability to stock up. The federal government started over with another company in 2014, whose ventilator was approved only last year [2019] and whose products have not yet been delivered.”

Resourceful doctors thinking outside of the box and rigging ventilators to treat multiple patients may therefore end up being among the many heroes of the COVID-19 pandemic.

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