As increasing numbers of people gather in shopping centers and stadia, on public transportation and in high-rise buildings, the likelihood of large-scale mass casualty disasters has dramatically risen.

High profile incidences over recent years, such as Covid-19, 9/11, the Moscow theatre siege, severe acute respiratory syndrome, H1N1, and the avian flu have raised awareness of the acute problem entailed in handling mass casualty situations caused by terror, accidents, pandemics or natural disasters.

Ventilators are at the center of the preparedness planning and emergency response debate. Man-made, natural disasters or pandemics could create a large number of victims who require ventilation. Until now, there has been no viable way to adequately ventilate mass casualties.

During a severe disaster such as a pandemic or chemical attack, many patients with respiratory failure who are able to receive mechanical ventilation may survive, while patients with respiratory failure who do not receive mechanical ventilation are likely to die. The Center for Disease Control (CDC) assumes that ventilators will be in short supply in many communities prior to or during the peak of a severe influenza or Coronavirus pandemic if something is not done.

In a recent report, the Center for Health Security at Johns Hopkins estimated the United States of America has a total of 160,000 ventilators available for patient. This leaves more than 99% of the United States population without any available form of ventilation in the event of a pandemic outbreak, such as coronavirus.

Current ventilator capacity and usage in the United States is about 75% to 95% utilized with existing cases (COPD, elderly, accident victims, trauma, post surgical, cardiac, etc).  A study run by the federal government in 2005 estimated that if the United States of America were hit with a moderate pandemic like the influenza of 1957, the country would need more than 60,000 ventilators. If the United States were struck with a severe pandemic like the Spanish flu of 1918, it is estimated we would need more than 740,000 ventilators — many times more than are available.

The solution is Biphasic Cuirass Ventilation. Biphasic Cuirass Ventilation does not require skilled medical professionals, and almost anyone can apply BCV to a patient with minimal training.  Currently, Endotracheal (ET) intubation is utilized in conjunction with positive pressure ventilation for respiratory support in patients with cardiac or respiratory arrest during emergent situations. Coupled with the shortage of qualified clinicians capable of managing endotracheal intubation, even with a stockpile of positive pressure ventilators, only a very limited number of patients can be treated. Using simple calculations, 1 study found that the limiting factor during a pandemic-level crisis, such as coronavirus would be the number of respiratory therapists rather than ventilators.

Medical emergency experts are seeking more feasible methods on how to treat large groups of people requiring immediate life saving ventilation. According to The U.S. Department of Health and Human Services (HHS) and the Biomedical Advanced Research and Development Authority (BARDA), there is a need for a ventilator that is portable, low-cost, user-friendly and flexible in a pandemic situation or other public health emergency. An affordable portable ventilator will help meet the needs of patients, especially those that are critically ill during a public health emergency whether from a natural pandemic or an act of chemical or biological attack. 

Strategic National Stockpile

Standard positive pressure ventilators require intensive training, clinical personnel to provide application, and are generally time consuming to apply. Combitube intubation is used for airway control and ventilation. Unfortunately, combitube intubation requires a skilled provider who performs this procedure on a frequent basis. During an emergency situation, ventilating patients quickly and effectively is key. In the event of a mass casualty scenario, such as a pandemic, this simply isn’t feasible. There are neither the facilities, nor the skilled personnel required for this to be achieved. With the Hayek MRTX, this is easily achieved.

In a mass casualty situation, persons of little medical skill will be required to care for patients. Biphasic Cuirass Ventilation does not require skilled medical professionals, and almost anyone can apply BCV to a patient with minimal training. BCV minimizes risks and complications, leading to significantly better patient outcomes during emergencies, including pandemics.  To the right is a comparison of the Hayek MRTX versus SNS/portable ventilators: 

Clinical Evidence

Exhibit A 

Application of a Cuirass and initiation of Biphasic Cuirass Ventilation by gear-protected physicians was investigated. In the study, 10 physicians of multiple specialties applied a cuirass shell on an adult patient. Biphasic Cuirass Ventilation was initiated using the Hayek RTX ventilator. ET intubation and manual ventilation of a mannequin were also reasonably evaluated. 
In conclusion, physicians wearing full protective gear applied a cuirass shell and instituted Biphasic Cuirass Ventilation much quicker than ET intubation and manual positive pressure ventilation. 


Exhibit B 

In another study Comparing the MRTX ventilator to positive pressure ventilation (PPV) in OP (paraoxon) poisoned pigs, three study groups were examined: 

  • Control – no ventilatory support 
  • PPV – using an airbag ventilation (more abundant measure; technical difficulty) 
  • Biphasic ventilation Using the MRTX 

There were a total of 23 animals – two were used as controls to establish the specific respiratory insult model, seven in every other group. Each animal was exposed to 1.2LD50 of paraoxon IM Atropine was given IM eight minutes post exposure. After ventilation was stopped, the MRTX group started to breath freely and independently, in contrast to the PPV and control groups. Survival Rate in each group: 

  • 33% of Control group survived with no ventilatory support 
  • 28% of the PPV group survived using an airbag ventilation 
  • 100% of the Biphasic ventilation group using the MRTX survived. 


Exhibit C 

The effect of BCV for acute respiratory failure through the patient of pandemic A (H1N1) influenza infection was examined. BCV (Continuous Negative Mode: CNEP) was used as respiratory management in 4 cases, and BCV (Secretion Clearance Mode: SC) was used as airway clearance in 8 cases. All 4 BCV (CNEP) cases had pneumonitis, respiratory distress and severe hypoxia. In 3 cases using BCV (CNEP), atelectasis was present. BCV (SC) with BCV (CNEP) was used to clear their airway 3 or 4 times a day. The patients recovered without intratracheal intubation. 
Overall, BCV was effective for pandemic A (H1N1) influenza. Especially, the direct effects that BCV (CNEP) provided from early respiratory distress, and as a result prevented serious illness. BCV (SC) prevented obstruction of the airways, and also aided patient’s to recover from marked obstructions (plastic bronchitis). 

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