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Oral Care Layered Enhancement for Improved Oral Hygiene in Intensive Care Units
Sponsor: Hospital do Coracao
Summary
The goal of the ORACLE study is to evaluate the impact of implementing a standardized oral hygiene bundle on outcomes in critically ill, mechanically ventilated patients. The primary objective is to determine whether this bundle can increase the number of ventilator-free days compared to the standard of care.
Official title: Oral Care Layered Enhancement for Improved Oral Hygiene in Intensive Care Units: A Stepped-Wedge Cluster Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
4800
Start Date
2025-09-01
Completion Date
2026-11-30
Last Updated
2025-08-19
Healthy Volunteers
No
Conditions
Interventions
Oral hygiene bundle
Implementation of the standardized oral hygiene bundle, which consists of the following key components: Standardization of materials used during the oral hygiene procedure, standardization of oral hygiene frequency, training of nursing staff involved in patient care on proper oral hygiene practices, discontinuation of routine application of chlorhexidine oral solution, and implementation of a standardized oral hygiene technique.
Locations (6)
Santa Casa de Misericordia de Passos
Passos, Minas Gerais, Brazil
Hospital Municipal de Maringa
Maringá, Paraná, Brazil
Hospital da Restauracao
Recife, Pernambuco, Brazil
Hospital Santa Cruz
Santa Cruz, Rio Grande do Sul, Brazil
Hospital Nereu Ramos
Florianópolis, Santa Catarina, Brazil
Hospital Leo Orsi
Itapetininga, São Paulo, Brazil