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Набор скоро начнётся NCT07129733

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

Без фазы С лечением Mechanical Ventilation Infection Prevention Oral Care Oral Hygiene, Oral Health

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Oral hygiene bundle.
Кому может быть актуально
Состояния в реестре: Mechanical Ventilation, Infection Prevention, Oral Care, Oral Hygiene, Oral Health. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бразилия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

  • Ventilator free days [Срок оценки: 28 days after enrollment]
Вторичные конечные точки (5)
  • Intensive Care Unit all cause mortality [Срок оценки: 15 months]
  • Hospital all cause mortality [Срок оценки: 15 months]
  • Ventilator associated pneumonia incidence [Срок оценки: 15 months]
  • Intensive care unit free days [Срок оценки: 28 days after enrollment]
  • Hospital free days [Срок оценки: 28 days after enrollment]

Критерии участия

Критерии включения

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

Критерии исключения

  • Does not meet inclusion criteria

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Бразилия · 6 центров
  • Santa Casa de Misericordia de Passos — Passos
  • Hospital Municipal de Maringa — Maringá
  • Hospital da Restauracao — Recife
  • Hospital Santa Cruz — Santa Cruz
  • Hospital Nereu Ramos — Florianópolis
  • Hospital Leo Orsi — Itapetininga

Публикации

  • Dale CM, Rose L, Carbone S, Pinto R, Smith OM, Burry L, Fan E, Amaral ACK, McCredie VA, Scales DC, Cuthbertson BH. Effect of oral chlorhexidine de-adoption and implementation of an oral care bundle on mortality for mechanically ventilated patients in the intensive care unit (CHORAL): a multi-center stepped wedge cluster-randomized controlled trial. Intensive Care Med. 2021 Nov;47(11):1295-1302. do PMID 34609548
  • Price R, MacLennan G, Glen J; SuDDICU Collaboration. Selective digestive or oropharyngeal decontamination and topical oropharyngeal chlorhexidine for prevention of death in general intensive care: systematic review and network meta-analysis. BMJ. 2014 Mar 31;348:g2197. doi: 10.1136/bmj.g2197. PMID 24687313
  • Bellissimo-Rodrigues WT, Menegueti MG, Gaspar GG, de Souza HCC, Auxiliadora-Martins M, Basile-Filho A, Martinez R, Bellissimo-Rodrigues F. Is it necessary to have a dentist within an intensive care unit team? Report of a randomised clinical trial. Int Dent J. 2018 Dec;68(6):420-427. doi: 10.1111/idj.12397. Epub 2018 May 18. PMID 29777534
  • Bellissimo-Rodrigues F, Bellissimo-Rodrigues WT. Ventilator-associated pneumonia and oral health. Rev Soc Bras Med Trop. 2012 Oct;45(5):543-4. doi: 10.1590/s0037-86822012000500001. No abstract available. PMID 23152333
  • Zhao T, Wu X, Zhang Q, Li C, Worthington HV, Hua F. Oral hygiene care for critically ill patients to prevent ventilator-associated pneumonia. Cochrane Database Syst Rev. 2020 Dec 24;12(12):CD008367. doi: 10.1002/14651858.CD008367.pub4. PMID 33368159
  • Klompas M, Branson R, Cawcutt K, Crist M, Eichenwald EC, Greene LR, Lee G, Maragakis LL, Powell K, Priebe GP, Speck K, Yokoe DS, Berenholtz SM. Strategies to prevent ventilator-associated pneumonia, ventilator-associated events, and nonventilator hospital-acquired pneumonia in acute-care hospitals: 2022 Update. Infect Control Hosp Epidemiol. 2022 Jun;43(6):687-713. doi: 10.1017/ice.2022.88. Epub 2 PMID 35589091
  • Marino PJ, Wise MP, Smith A, Marchesi JR, Riggio MP, Lewis MAO, Williams DW. Community analysis of dental plaque and endotracheal tube biofilms from mechanically ventilated patients. J Crit Care. 2017 Jun;39:149-155. doi: 10.1016/j.jcrc.2017.02.020. Epub 2017 Feb 16. PMID 28259058
  • van Nieuwenhoven CA, Buskens E, Bergmans DC, van Tiel FH, Ramsay G, Bonten MJ. Oral decontamination is cost-saving in the prevention of ventilator-associated pneumonia in intensive care units. Crit Care Med. 2004 Jan;32(1):126-30. doi: 10.1097/01.CCM.0000104111.61317.4B. PMID 14707570

Идентификаторы

NCT: NCT07129733 · ip_hcor_oracle

Первоисточники (государственные реестры)

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