COVID Airway Tracheostomy Device - Reduce Infection & Ventilator Time

Importance of Tracheostomy in COVID

Improved Patient Outcomes

Video Description: Insertion Comparison of COVID Airway vs Standard Device 

The COVID Airway tracheostomy device is the first all-in-one device consisting of an integral introducer and tracheostomy tube. Its platform insertion technology enables controlled, rapid, and safe airway access via familiar simpler insertion techniques. The COVID Airway can have a large impact on decreasing hospital costs and mortality by reducing tissue damage, infection and ventilator time. Patents for the device are issued to inventors Julia S. Rasor and Ned S. Rasor and are now for sale or license.

Patients are connected to ventilators by an airway device, either an endotracheal tube via the mouth or a tracheostomy tube via insertion through the neck tissue. Tracheostomy has shown benefits over endotracheal intubation in COVID-19 patients.

Recently, some centers in New York City have found early tracheostomy has improved management of COVID-19 patients. In July 2020, based on a strong consensus,

an expert panel recommends the consideration of tracheostomy in patients with COVID-19 if clinicians anticipate mechanical ventilation will be required.

The current literature suggests the tracheostomy procedure may confer better outcomes, such as ventilator-free days, shorter hospital stays, shorter stays in the ICU, and reduced hospital-acquired pneumonia incidence.

Poor survival rates have been published for intubated critical patients without tracheostomy infected with COVID-19 admitted to ICUs, with mortality rates in large case reports of 26–54.4%. Comparatively, in a large collaborative study where 1,616 tracheostomies were performed the overall COVID-19-associated mortality was 23.7%. 

Recent results in 2,081 COVID-19 patients undergoing tracheostomy suggest that tracheostomy could be effective in the weaning and decannulation of COVID-19 patients.

Improved Healthcare Worker Safety

Procedures such as airway suctioning, manipulation of oxygen face masks, endotracheal intubation, and tracheostomy are aerosol-generating procedures that increase the risk of COVID-19 infection transmission to healthcare workers. Endotracheal intubation is especially hazardous because the clinician is close to the patient’s airway before, during, and after the procedure.

Increased safety to healthcare workers is provided by using a tracheostomy airway with a ventilator as breathing by the patient is contained in a closed system.

Improved Resource Availability

Tracheostomy is particularly important in treating patients with COVID-19 where resource capacity is already stretched to the brink, earlier tracheostomy can:

  • free up ICU beds
  • free up ventilators
  • free up staff 
  • reduce PPE use.

Presently, “Tracheostomy Related Devices” are listed under “Ventilation-Related Products” in the list of device types that FDA believes are critical to the public health during the COVID-19 pandemic under section 506J(a)(1) so demand is high for these airway products.

Standard Airway

Standard tracheostomy tubes have significant insertion complications such as tissue damage and perforations from the high forces needed to dilate tissue and advance the introducers and respiratory and visualization compromise from airway deformation. They also have long-term complications such as rubbing, pressure necrosis, scarring, and infection from biofilm buildup which can lead to deadly ventilator-associated pneumonia (VAP) and to surgical site infection. Existing tracheostomy products are complicated and use multiple tools that increase infection risk and tissue damage. Also, tracheostomy tubes and their bulky introducer sets are disposables contributing a large volume of medical waste.

COVID Airway

The COVID Airway tracheostomy device’s platform insertion technology enables controlled, rapid, and safe airway access via simpler insertion techniques. The platform consists of laying down a thin-walled protective film sheath during advancement (everting). Everting eliminates friction-related tissue trauma (read Julia’s Special Feature article ‘The Science of Friction’), introduction of microbes from the skin into the airway, and build-up of microbial biofilms during prolonged airway placement. The COVID Airway has the potential to have a large impact on decreasing hospital costs and mortality by reducing tissue damage, infection and ventilator time.

Patents for the device are issued and are now for sale or license. Due to the novel coronavirus (COVID-19) global pandemic, the COVID Airway patents are a timely offering as they cover an airway device that is used with a ventilator that offers infection prevention to both the patient and the healthcare worker. At this time, there are government funds available as well as expertise and core services to support development projects for COVID-related medical devices, tracheostomy tubes are included in the “Medical Supplies” and “Respiratory Protective Devices”. In addition, “Tracheostomy Related Devices” are listed under “Ventilation-Related Products” in the list of device types that FDA believes are critical to the public health during the COVID-19 pandemic under section 506J(a)(1).

Read more COVID Airway Tracheostomy Patents.