Abstract
AIM: The primary aim of this study is to compare an oropharyngeal suction intervention versus usual care on microaspiration in intubated patients. Secondary aims are to evaluate the intervention on ventilator-associated condition rates, time to occurrence and compare tracheal-oral α-amylase ratios between groups. DESIGN: Prospective randomized clinical trial. METHODS: The study received funding from the National Institutes of Health in February 2014 and Institutional Review Board approval in July 2013. Over 4 years, a convenience sample of 600 orally intubated, ventilated adult patients will be enrolled within 24 hr of intubation. The target sample is 400 participants randomized to the two groups. The intervention involves enhanced suctioning of the mouth and oropharynx every 4 hr, while the usual care group receives a sham suctioning. The research team will deliver usual oral care to all patients every 4 hr and collect oral and tracheal specimens every 12 hr, to quantify α-amylase levels to detect aspiration of oral secretions. Study completers must be enrolled at least 36 hr (baseline and three paired samples). Outcomes include α-amylase levels, percent of positive specimens, ventilator-associated conditions, length of stay, ventilator hours, and discharge disposition. DISCUSSION: Enrolment has closed, and data analysis has begun. Subgroup analyses emerged, contributing to future research knowledge. IMPACT: Standardized interventions have reduced but do not address all risk factors associated with ventilator-associated conditions. This study provides the potential to reduce microaspiration and associated sequelae in critically ill, intubated patients.