The long-term goal of the proposed research is to reduce morbidity, mortality, and costs associated with ventilator-associated pneumonia (VAP). Critically ill patients who require mechanical ventilation are at high risk for VAP, a complication that results in (a) prolonged lengths of stay in the intensive care unit and hospital; (b) increased costs; (c) morbidity; and (d) mortality. Mechanical ventilation is provided via an artificial airway, the endotracheal tube (ETT). The ETT has a balloon or cuff at the distal end that is inflated to create a seal in the trachea. The ETT cuff pressure must be maintained within an optimal range that is high enough to ensure ventilation and prevent aspiration, yet low enough to ensure perfusion of the tracheal wall. While guidelines for optimal ETT cuff pressure have been established, maintaining pressure within an optimal range requires monitoring and attention to pressure variation. The current standard of care is intermittent measurement and adjustment of ETT cuff pressures every 8 to12 hours. This exploratory study proposes implementation of continuous monitoring of ETT cuff pressures to: 1) Identify clinical factors that influence ETT cuff pressures; 2) describe the natural history of ETT cuff pressures; and 3) test the effectiveness of an innovative airway management intervention-continuous monitoring of ETT cuff pressures with alarm triggers-versus the standard of care, on maintaining ETT cuff pressures within an optimal range. A randomized crossover design will be used. Subjects (n = 32) will be age 18 or older, have an oral ETT, and require mechanical ventilation. During the control period, ETT cuff pressures will be monitored continuously (but blinded to the investigators), and adjusted according to the standard of care. During the intervention, ETT cuff pressures will be continuously monitored, and pressures will be adjusted to optimal levels based on alarm triggers. Throughout both control and intervention periods, patient activities and nursing interventions will be recorded to assess effects on ETT cuff pressures. Data analysis will include repeated measures analysis, functional principal component analysis, and functional analysis of variance. Our hypotheses are that clinical factors will affect ETT cuff pressures, pressures will decrease over time, and that the novel intervention will be more effective than the standard of care in maintaining optimal cuff pressures. Improved management of the endotracheal tube may reduce the risk of ventilator associated pneumonia in critically ill patients and its associated morbidity and mortality. Findings will assist in designing airway management interventions and technologies to improve the outcomes of critically ill patients, and inform the development of an intervention/technology package to reduce VAP. ? ? ?
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