Can a dental care intervention reduce the risk of death among critical patients? A stepped-wedge 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 death and the risk of death attributable to nosocomial lower respiratory-tract infections among adult patients admitted to Intensive Care Units (ICUs). This is a cross-over cluster randomized clinical trial study. The study population will consist of any adult patient admitted to one of the six ICU selected from the study facility during the period of June 4, 2018 to May 31, 2020. During this period, we expect to include and evaluate up to 1,856 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 death according to the study allocation and it will be assessed at the end of the ICU staying. The study secondary outcomes include: the incidence of lower respiratory-tract infections; 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. (AU)