Effectiveness of a Novel Respirator With Chitosan Nanoparticles
Condition: Covid19; SARS-CoV Infection; Worker-Patient Transmission, Healthcare
MeSH terms: Infections; Severe Acute Respiratory Syndrome
Study type: Interventional

Summary: 
      The use of nanomaterials in semi-facial respirators could decrease the permeability of
      particles and promote a biocidal effect compared to conventional respirators (N95) and,
      therefore, to enhance the filtering power, aiming to mitigate harmful effects of bacteria and
      viruses. Chitosan is a natural cationic polymer derived from chitin, with characteristics
      such as being biodegradable, biocompatible, non-toxic, and presenting antimicrobial activity.
      This polymer has virucidal activity in several types of viruses, including other
      coronaviruses, given the attractive factor of its cationic charge for negative charges. The
      effectiveness of a novel individual protection semi-facial respirator (called VESTA) will be
      investigated, compared to a conventional N95 respirator. The respirators will be tested in
      healthcare professionals working in hospital environments and the effectiveness will be
      attributed to the lower incidence rate of infection by the SARS-CoV-2, and to the ability to
      filter these viruses after use by healthcare professionals exposed to potentially
      contaminated environments. The study will be carried out in two stages: i) Randomized
      Controlled Trial with reduced sample to confirm the sample size calculation (pilot trial),
      and ii) Randomized Controlled Trial (RCT). The RCT will be conducted with healthcare
      professionals who have contact with environments/patients infected by SARS-CoV-2 in hospital
      sectors with greater vulnerability to infection (urgency, emergency and intensive care
      units). The RCT will be conducted initially with a group of sixty participants (n = 30 in
      each group) for initial investigation of the potential for efficacy with the use of the
      respirators (VESTA and conventional N95) in two sectors (emergency and ICU) in a reference
      Hospital for COVID-19. The RCT will consist of two parallel groups: (1) Experimental Group
      (GExp) that will use the novel respirator (VESTA) and (2) Control Group (CG) that will use
      the standard respirator (N95). Participants will be recruited from participating hospitals
      and will be accompanied by 21 days in approximately eight consecutive shifts (ranging from
      shifts lasting 6 to 12 hours each, followed by approximately 36 hours of rest). Participants
      will be assessed at baseline (T0), at the end of the 10th day (T1), and at the end of the
      21st day (T2).
    

Detailed description: 
      Context for the latest register update (May, 2022): Our randomized controlled pilot trial was
      conducted from February until April 2021, following the same methodological procedures
      described within the clinical trial register. After analyzing the data from the pilot trial
      we included some updates within the clinical trial register. Summary of changes after the
      pilot trial: 1) We performed a new sample size calculation, which resulted in a sample size
      of 700 participants (n=350 in each group). This information was updated within the trial
      register; 2) We removed the secondary outcome "Ability of the filtering element to inactivate
      the SARS-Cov-2". The team decided that this outcome would be more appropriately assessed in a
      controlled laboratory study, and not associated with the clinical trial. Thus, this outcome
      will be investigated in a secondary study; 3) We decided to include the clinical assessments
      (Job stress, Quality of life, Musculoskeletal discomfort, Burnout, and Work ability)
      exclusively as baseline measurements.
    

Intervention name(s): VESTA respirator; Conventional N95 respirator
Intervention type(s): Device; Device
Intervention description(s): The protocol will be composed by the use of the VESTA respirator for 21 days (approximately 8 consecutive shifts lasting 6 to 12 hours, followed by approximately 36 hours of rest). Each participant will receive a total of approximately 8 respirators, with instructions for a maximum usage time of 6 hours. Therefore, participants will receive 1 respirator to be used in each shift of 6 hours, and 2 respirators in shifts of 12 hours. All participants will receive a booklet with guidelines and training in the use and proper handling of the respirator. All respirators will be sterilized and packaged in the laboratory, to ensure that they are not contaminated before use by the participants. The intervention will not change the participants' routine, considering that they already follow instructions for the use of protective personal equipment (PPE) and the proposed intervention will follow all local regulations and guidelines for the use and conservation of PPE and semi facial respirators.; The protocol will be composed by the use of the N95 respirator for 21 days (approximately 8 consecutive shifts lasting 6 to 12 hours, followed by approximately 36 hours of rest). Each participant will receive a total of approximately 8 respirators, with instructions for a maximum usage time of 6 hours. Therefore, participants will receive 1 respirator to be used in each shift of 6 hours, and 2 respirators in shifts of 12 hours. All participants will receive a booklet with guidelines and training in the use and proper handling of the respirator. All respirators will be sterilized and packaged in the laboratory, to ensure that they are not contaminated before use by the participants. The intervention will not change the participants' routine, considering that they already follow instructions for the use of protective personal equipment (PPE) and the proposed intervention will follow all local regulations and guidelines for the use and conservation of PPE and semi facial respirators.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized controlled clinical trial, characterized by the application of semi facial respirators, in which participants will be randomly and concealed allocated into two groups: VESTA respirator (GExp) and Conventional N95 respirator (CG). The participants will be healthcare professionals working in hospital environments contaminated by SARS-Cov-2. The study will be reported following the recommendations of the CONSORT Statement.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Protective personal equipment; SARS-Cov-2; Chitosan; Occupational health; Prevention