Nursing Oral Suction Intervention to Reduce Aspiration and Ventilator Events (NO-ASPIRATE): A Randomized Clinical Trial.

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 four years, a convenience sample of 600 orally-intubated, ventilated adult patients will be enrolled within 24 hours of intubation. The target sample is 400 subjects randomized to the two groups. The intervention involves enhanced suctioning of the mouth and oropharynx every four hours, while the usual care group receives a sham suctioning. The research team will deliver usual oral care to all subjects every four hours and collect oral and tracheal specimens every 12 hours, to quantify α-amylase levels to detect aspiration of oral secretions. Study completers must be enrolled at least 36 hours (baseline and three paired samples). Outcomes include amylase levels, percent of positive specimens, ventilator associated conditions, length of stay, ventilator hours and discharge disposition.

DISCUSSION: Enrollment has closed, and data analysis began. 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 sequelas in critically ill, intubated patients. This article is protected by copyright. All rights reserved.