跳至主要内容
临床试验/NCT07129733
NCT07129733尚未招募不适用

Oral Care Layered Enhancement for Improved Oral Hygiene in Intensive Care Units: A Stepped-Wedge Cluster Randomized Clinical Trial

Hospital do Coracao6 个研究点 分布在 1 个国家目标入组 4,800 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
4,800
试验地点
6
主要终点
Ventilator free days

研究概览

简要总结

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.

详细描述

The use of invasive mechanical ventilation (IMV) as an organ support measure is common in intensive care units (ICUs), with its prevalence ranging from 36% to 89%. Lower respiratory tract infections (LRTIs) are known to be the primary site of infection related to sepsis in critically ill patients in Brazilian ICUs and are associated with high morbidity and mortality.

It is well established that the oral cavity is a source of pathogens leading to LRTIs in critically ill patients, with dental plaque serving as an important reservoir of these pathogens. Therefore, oral hygiene in critically ill patients is an essential measure for the prevention of LRTIs, as recommended by both international and national guidelines.

Simple cleaning of the oral cavity using a toothbrush or oral swab, in addition to providing comfort and well-being to the patient, contributes to the prevention of LRTIs and other infections. A recent meta-analysis evaluating the impact of standardized toothbrushing on clinical outcomes showed that this care intervention was associated with a lower incidence of LRTIs and reduced mortality. On the other hand, an international clinical trial demonstrated that the implementation of an oral care bundle combined with the de-implementation of chlorhexidine for oral care was not associated with improved outcomes.

Based on the rationale supporting the benefits of implementing a standardized oral care, findings from previous studies, the conflicting literature regarding the effectiveness of oral care protocols that include the de-implementation of chlorhexidine on clinical outcomes in ICU patients, and the scarcity of data from developing countries such as Brazil, conducting a clinical trial is needed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All patients who receive mechanical ventilation in the participating intensive care units

排除标准

  • •Does not meet inclusion criteria

研究组 & 干预措施

Oral hygiene bundle

Experimental

This arm will receive the standardized oral hygiene bundle

干预措施: Oral hygiene bundle (Other)

Standard of care

No Intervention

Each center will maintain its usual oral care practices.

结局指标

主要结局

Ventilator free days

时间窗: 28 days after enrollment

Days alive and free from mechanical ventilation

次要结局

  • Intensive Care Unit all cause mortality(15 months)
  • Hospital all cause mortality(15 months)
  • Ventilator associated pneumonia incidence(15 months)
  • Intensive care unit free days(28 days after enrollment)
  • Hospital free days(28 days after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruno Martins Tomazini

MD

Hospital do Coracao

研究点 (6)

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