Usability of a 3D Printed Face Shield Prototype for Intensive Care Professionals: Pragmatic Clinical Trial

INTERVENTION: The present study is designed as a pragmatic non‐inferiority clinical trial (PCT), with parallel groups, and allocation ratio of 1:1. The study protocol was developed using the guidelines contained in CONSORT (Consolidated Standards of Reporting Trials). Participants will be randomly assigned to either an intervention group (SOMA Adjustable Reusable Face Shield) or a comparator group (institution‐standardized Face Shield). The present study will be carried out in the premises of the Intensive Care Units of the Complexo Hospitalar do Trabalhador, of the Secretary of State for Health of Paraná (SESA). Will be eligible for participation in this study: nursing professionals working in intensive care units who care for patients with infectious respiratory diseases that require the use of face shields during work activities; any provider with practical experience using respiratory PPE, and who has used a face shield, regardless of frequency of use. After validating the eligibility criteria, each participant will be randomly assigned to the intervention arm (prototype) or to the control arm (usual equipment). The allocation ratio will be 1:1 (GC or GE). All participants will be informed about the two groups. The randomization process will be carried out by applying the Research Randomizer online software (www.randomizer.org) to assign participants to one of the groups. Automated randomization will be performed after receipt of all necessary data and consent from the subject to participate in the study. Sequentially generated numbers will be placed in sealed and sealed opaque envelopes. All participants will be informed about the existence of intervention and control groups. Groups will be analyzed in terms of outcomes of interest defined by the study protocol. Over the segment CONDITION: E07.700.560 Equipment Safety PRIMARY OUTCOME: The evaluated outcomes will be the usability attributes: efficiency, effectiveness and satisfaction. There will be no hierarchy between the different attributes for classification, considering their interrelationship. SECONDARY OUTCOME: As a secondary outcome, the occurrence of potential adverse effects during the use of face shields in the intervention and control groups will be documented. INCLUSION CRITERIA: Nursing professionals working in intensive care units