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Oral Care Layered Enhancement for Improved Oral Hygiene in Intensive Care Units

NCT07129733 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4800

Last updated 2025-08-19

No results posted yet for this study

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.

Conditions

  • Mechanical Ventilation
  • Infection Prevention
  • Oral Care
  • Oral Hygiene, Oral Health
  • VAP - Ventilator Associated Pneumonia

Interventions

OTHER

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.

Sponsors & Collaborators

  • Faculdade de Medicina de Ribeirão Preto/USP

    collaborator UNKNOWN

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Fernando Belissimo-Rodrigues, MD, PhD · Faculdade de Medicina de Ribeirão Preto da USP

  • Bruno M Tomazini, MD · Hospital do Coração (Hcor)

  • Wanessa Belissimo-Rodrigues, PhD · Faculdade de Medicina de Ribeirão Preto da USP

  • Alexandre Biasi Cavalcanti, MD, PhD · Hospital do Coração (Hcor)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Brazil

Study Locations

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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 NCT07129733 on ClinicalTrials.gov