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A Human Factors Simulation Study Protocol for the Assessment of Usability of Innovative Personal Protective Equipment

NCT06266078 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-02-20

No results posted yet for this study

Summary

Background: Many factors influence Personal Protective Equipment (PPE) compliance for use in health care, specifically the PPE usability and related human factors. It is known that issues related to the usability of new technologies, including professional behavioral and attitudinal patterns, the technologies adoption within the workflow and teamwork strengths can be investigated by using Simulation-Based Research (SBR) before its implemented. This study aims to develop and validate a simulation protocol for the assessment of human factors and usability of innovative PPEs used in critical care units. The ultimate goals is to define a standard method for PPEs assessment and comparison worldwide. Method: methodological study with a quantitative approach to be carried out in two phases: a) development and validation by experts of a simulation protocol; b) piloting of the simulation protocol. For the protocol validation phase, 14 experts with experience in the themes of infection prevention and control or clinical simulation will be included. The experts will be invited via email and will assess the simulation protocol content using the criteria of pertinence, clarity and relevance. To ensure that the simulation protocol is feasible and reliable, a piloting phase will take place at the simulation center in São Paulo and 36 health professionals with work experience in critical care units will be included. The health professionals will perform specific tasks assigned to them, wearing pre-defined PPEs in each simulation round. Errors and difficulties during PPE assembly, donning and doffing; performance of individual and team activities, as well as communication problems and self-contamination risk, will be observed during the tasks. At the end of the simulation round, the participants will take part in a debriefing, where they will answer questionnaires about comfort, perception of safety, thermal sensations, usability and perceived workload related to the PPE used. Content validity index (CVI) and intraclass correlation coefficient (ICC) will be calculated. This study protocol was approved by the Research Ethics Committee of the School of Nursing, University of São Paulo. The informed consent form will be applied both to the experts and to the health care workers.

Conditions

  • Personal Protective Equipment

Interventions

DEVICE

Innovative PPE

The healthcare workers will perform tasks using innovative personal protective equipments, such as LightWeight Powered Air-Purifying Respirator (PAPR) or other type of PAPR and a Sealed coverall

DEVICE

Traditional PPE

The healthcare workers will perform tasks using usual personal protective equipments, such as N95 mask plus Faceshield and waterproof apron.

Sponsors & Collaborators

  • University of Campinas, Brazil

    lead OTHER

Principal Investigators

  • Maria Clara Padoveze, PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-06-01
Completion
2024-12-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06266078 on ClinicalTrials.gov