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

Usability Evaluation of a High Fidelity Face Shield Prototype Developed for Intensive Care Health Professionals: Pragmatic Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10bzg6v2
Enrollment
Unknown
Registered
2023-08-14
Start date
2023-08-30
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Equipment Safety

Interventions

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
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 random

Sponsors

Pontifícia Universidade Católica do Paraná
Lead Sponsor
Pontifícia Universidade Católica do Paraná
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Nursing professionals working in intensive care units

Exclusion criteria

Exclusion criteria: Professionals on probationary period (less than 3 months in the hospital); professionals in the process of dismissal (with prior notice); pregnant professionals; intolerance or allergies (formal or declared) to face shield materials

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactMichel Dalmedico

Pontifícia Universidade Católica do Paraná

micheldalmedico@yahoo.com.br55 (41) 99908-7730

Outcome results

None listed

Source: REBEC (via WHO ICTRP)