Simulation-Based Rapid Development and Implementation of a Novel Barrier Enclosure for Use in COVID-19 Patients: The SplashGuard CG

Abstract

Background. The current COVID-19 pandemic has resulted in over 54,800,000 SARS-CoV-2 infections worldwide with a mortality rate of around 2.5%. As observed in other airborne viral infections such as influenza and SARS-CoV-1, healthcare workers are at high risk for infection when performing aerosol-generating medical procedures (AGMP). Additionally, the threats of a global shortage of standard personal protective equipment (PPE) prompted many healthcare workers to explore alternative protective enclosures, such as the “aerosol box” invented by a Taiwanese anesthetist. Our study includes the design process of a protective barrier enclosure and its subsequent clinical implementation in the management of critically ill adults and children infected with SARS-CoV-2. Methods and Results. The barrier enclosure was designed for use in our tertiary care facility and named “SplashGuard CG” (CG for Care Givers). The device has been adapted using a multi- and interdisciplinary approach, with collaboration between physicians, respiratory therapists, nurses, and biomechanical engineers. Computer-aided design and simulation sessions throughout the entire process facilitated the rapid and safe implementation of the SplashGuard CG in different settings (intensive care unit, emergency department, and the operating room) during AGMPs such as bag-valve-mask ventilation, nasopharyngeal suctioning, intubation and extubation, and noninvasive ventilation. Indications for use and anticipatory precautions were communicated to all healthcare workers using the SplashGuard CG. The entire process was completed within one month. Conclusion. The rapid design, development, and clinical implementation of a new barrier enclosure, the “SplashGuard CG,” was feasible in this time of crisis thanks to close collaboration between medical and engineering teams and the use of recurring simulation sessions to test and improve the initial prototypes. Following this accelerated process, it is necessary to maintain team skills, monitor any undesirable effects, and evaluate and continuously improve this new device.

A special oropharyngeal oxygenation device to facilitate apneic oxygenation in comparison to high flow oxygenation devices

“… 26 Using HFNO devices that are known to create large amounts of highly infectious aerosols in the surrounding of patient may pose an additional risk of infection for the physician who attempts intubation, and requires high levels of personal protective equipment. 27 Thus, the availability of a non-commercial OOD that could simply be constructed, may be an additional tool to maintain patient’s oxygenation for awake fiberoptic intubation. Due to significantly lower gas flows, one might postulate that fewer infectious areosols might be produced during the use of these devices.…”

Efficiency of different flows for apneic oxygenation when using high flow nasal oxygen application – a technical simulation

“…This has gained much attention especially at the beginning of the COVID-19 pandemic. Fear of virus transmission and subsequently infection caused by infective aerosols [ 11 – 13 ] has even led to the recommendation to avoid high flow nasal oxygen therapy in COVID-19 patients at the beginning of the pandemic. Thus, the lowest possible air flow that maintains adequate oxygen concentrations in a lung during intubation may be considered the optimum from this aspect.…”

Effectiveness of a novel semi‐closed barrier device with a personalized exhaust in cough aerosol simulation according to particle counts and visualization of particles

“…16 , 17 , 18 However, a tight seal may increase the risk of hypercarbia as well as cause difficulties for healthcare professionals in terms of treating and caring for patients. 19 Fidler et al 17 found increased aerosol leakage through arm apertures with a tighter seal on the opposite side of the barrier device. In contrast, our SB allows leakage from the bottle edge of the transparent soft area around the bed edge, avoiding aggregating leakage through the space opened by inserting forearms under a soft transparent barrier sheet.…”

“…To prevent aerosol dispersion, many barrier devices, including closed, semi‐closed, and semi‐open devices mainly designed for short‐term use (eg, tracheal intubation, endoscopy, and tracheostomy), are necessary to create a tight seal and suction to increase the isolation effect through negative pressure 16‐18 . However, a tight seal may increase the risk of hypercarbia as well as cause difficulties for healthcare professionals in terms of treating and caring for patients 19 . Fidler et al 17 found increased aerosol leakage through arm apertures with a tighter seal on the opposite side of the barrier device.…”

“…Hypoxemia and cough are the main symptoms among patients with coronavirus disease (COVID- 19), and hypoxemia is the primary reason for hospital admission. Oxygen therapy is the mainstay therapy for treating hypoxemia.…”