The use of a surgical helmet system with a high-efficiency particulate air filter as possible protection equipment during the coronavirus disease 2019 pandemic: a double-blinded randomized control study.

ABSTRACT

PURPOSE: The rapid spread of coronavirus disease 2019 (COVID-19) has increased the use of personal protective equipment. The purpose of this study was to investigate whether a commercially available sterile surgical helmet system (SSHS) can be considered protective against COVID-19 and therefore safe for use. METHODS: A double-blinded randomized controlled study was performed to investigate the efficacy of the ViVi® SSHS with a high-efficiency particulate air filter called HFD Hood (THI, Total Healthcare Innovation GmbH, Feistritz im Rosental, Austria) to protect against respiratory droplets. Forty recruited participants were divided into two different groups. The SSHS was tested using a validated qualitative test for respirator masks through saccharin or placebo solutions based on random allocation into two cohorts. Saccharin droplets are a validated surrogated marker for any elements of viral size, such as coronaviruses. A positive report of sweet taste after saccharin exposure was suggestive of ViVi® SSHS inefficacy in protection against droplets. RESULTS: One participant out of 21 (4.8%) reported positive for taste within the placebo cohort, while five out of 19 (26.3%) reported positive for taste within the saccharin cohort upon testing. Two out of 21 (9.5%) participants reported positive for taste within the placebo cohort, and two out of 19 (10.5%) reported positive for taste within the saccharin cohort upon retesting. There were no statistically significant differences between the saccharin and placebo groups in either the test or retest measurements (p = 0.085 and p = 1.000, respectively). CONCLUSIONS: This study demonstrates that the ViVi® SSHS equipped with HFD Hood protects against respiratory droplets, increasing protection against several microorganisms, including the virus that causes COVID-19, allowing surgeons to carry out procedures on COVID-positive patients in a more comfortable and safer way.