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Can a dental care intervention reduce the risk of respiratory tract infections among critical patients? A cross-over cluster-randomized clinical trial

Abstract

The development of the intensive care along the past century has profoundly changed the management of critical patients, making possible today to save the life of many patients previously considered irreversible dying. On the other hand, intensive care is not risk-free. Our aim is to evaluate the impact of a dental care intervention on the overall risk of developing nosocomial lower respiratory-tract infections among adult patients admitted to intensive care units (ICUs). This is a cross-over cluster-randomized clinical trial. The study population will consist of any adult patient admitted to one of the four ICU selected from the study facility during the period of July 1, 2019 to July 31, 2020. During this period, we expect to include and evaluate up to 1,685 patients. The intervention will consist of providing individually customized dental treatment, performed by dentists, at the minimum frequency of 3 times a week, in addition to the routine oral care, provided by the ICU nursing staff. In the control period, admitted patients will be submitted to the routine oral care, provided by the nursing staff. Despite the cluster randomization, the study outcomes will be accessed on the individual level. The study primary outcome will be the relative risk of developing nosocomial lower respiratory-tract infections according to the study allocation and it will be assessed at the end of the ICU staying. The study secondary outcomes include: the relative risk of dying due to a lower respiratory-tract infection episode, the survival time free from lower respiratory-tract infections in the ICU, the length of mechanical ventilation, the duration of antimicrobial treatment, and the length of stay in the ICU. The primary study outcome will be assessed by means of a logistic regression model, which will include the following as independent variables: dental care, sex, age, SAPS3 score at admission, unit of admission, and sequence of intervention. (AU)

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