Clinical Trial on the Efficacy of Different Masks With and Without a Peripheral Sealing Device, Against Covid-19
Condition: Covid19; Personal Protective Equipment
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      A significant number of professionals subjected to high-risk situations have been infected by
      Covid-19, due to the lack of adequate respiratory protection equipment or poor marginal
      sealing adjustments. Then, the objective of this study is to determine if there are
      statistically significant differences in the level of respiratory protection of type IIR
      surgical face masks and filtering face masks, used with and without a peripheral sealing
      device, against the contagion of Covid-19 or other harmful biological agents. The proposed
      device is a thermoplastic resin ring composed of a reusable and biodegradable polylactic acid
      designed to be used in a healthcare environment. The individuals of the study will be
      submitted to qualitative fit tests, that meet current Ocupational Security and Health
      Administration (OSHA) standard. The mentioned qualitative fit test uses a sodium saccharin
      solution to evaluate the respiratory protection equipment in professionals in hospitals,
      emergency centers, and early childhood education centers.
    

Detailed description: 
      The purpose of the research is to determine if there are statistically significant
      differences in the level of respiratory protection in situations of high risk against the
      contagion of Covid-19 or other harmful biological agents, in subjects who use filtering face
      pieces (FFP2) with or without a peripheral sealing device (AMS), Type IIR surgical face masks
      with or without a AMS, and subjects using the FFP2 filtering face mask simultaneously with
      the Type IIR surgical face mask. For this, a total of 210 individuals were selected from
      different environments in order to attain diversity, while controlling for representativeness
      bias. They were selected from the ADEMA University School - UIB, nursing staff from the
      Infectious Diseases Service at Son Espases University Hospital, 112 Emergency Service of the
      Autonomous Community of the Balearic Islands and the General Directorate of Planning and
      Centers of the Ministry of Education and Professional Training (Balearic Islands, Spain).

      Participants were assigned to one of the 5 groups and subgroups, after accepting their
      participation in the study voluntarily and freely by signing the consent form approved by the
      CEI-IB.

      To evaluate the adjustment of the respiratory protective equipment with and without the
      personalized peripheral sealing device (AMS), a sweet sensitivity test was performed with the
      3M FT-10 Qualitative Fit-Test Kit (Saint Paul, Minnesota, USA), which complies with the
      current standards of the Occupational Security and Health Administration (OSHA) and according
      to the protocol described in Riutord-Sbert et al. (2021). During the qualitative fit test, a
      total of seven mobility exercises of 60 seconds each were performed, and the nebulizer was
      squeezed, every 30 seconds:

      Phase 1 - Normal breathing Phase 2 - Slow and deep breathing Phase 3 - Breathing whilst
      moving the head to both sides Phase 4 - Breathing whilst moving the head up and down Phase 5
      - Breathing spelling the alphabet Phase 6 - Breathing whilst moving up and down from the
      waist Phase 7 - Normal breathing

      If the fit test was completed within 7 minutes without the individual having detected the
      sweet taste, the seal was considered optimal or adequate and the experiment was graded as
      APPROVED. If the subject detected the sweet test before seven minutes, the adjustment was
      considered inadequate and was scored as FAILED, noting the time it took to detect the sweet
      taste as established in the protocol of the 3M FT-10 Fit test (Riutord-Sbert et al. 2021).
    

Intervention name(s): Peripheral sealing device for surgical mask or filtering face piece; IIR Surgical mask with Filtering face piece
Intervention type(s): Device; Device
Intervention description(s): The individuals used a Peripheral Sealing Device on a surgical mask or a filtering face piece mask and were submitted to a qualitative fit test, regulated by the Occupational Security and Health Administration (USA).; The individuals used a IIR surgical mask with a filtering face piece mask and were submitted to a qualitative fit test, regulated by the Occupational Security and Health Administration (USA).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research