This trial will study the impact of a combined strategy to prevent microaspiration of oropharyngeal secretions or gastric content using automated subglottic secretion drainage and/or continuous cuff pressure monitoring. These measures aim at preventing secretions of oropharyngeal or gastric origin from entering lower respiratory tracts of patients under invasive mechanical ventilation in intensive care units (ICU), referred to as microaspiration, in the hope of preventing ventilator-associated pneumonia, a condition associated with patient outcome worsening. Patients will be randomly assigned to one of four groups: a combined strategy group using both automated techniques, 2 groups using either one or the other automated technique, and a control group using standard of care. Microaspiration will be detected by measuring concentration of oropharyngeal (amylase) or gastric (pepsin) enzymes in tracheal aspirates.
Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
800
Subglottic secretion drainage and cuff pressure monitoring will be performed using automated bedside devices
Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually.
Tracheal cuff pressure will be monitored continuously using an automated bedside device. Subglottic secretion drainage will be performed manually
Both tracheal cuff pressure monitoring and subglottic secretion drainage will be performed manually and discontinuously
Frequency of global abundant microaspiration
Microaspiration of oropharyngeal secretions will be detected by measuring amylase concentration levels in tracheal aspirates Microaspiration of gastric content will be detected by measuring pepsin concentration levels in tracheal aspirates Global abundant microaspiration will be defined by a proportion of at least 30% of tracheal aspirates with significant amylase and/or pepsin concentrations
Time frame: 48 hours after inclusion
Ventilator-associated pneumonia incidence
The incidence of ventilator-associated pneumonia (VAP) will be assessed using the 2005 IDSA/ATS guidelines. VAP will be suspected when a new or progressing chest X-ray infiltrate is associated to at least 2 criteria among: fever \> 38 °C or \< 35 °C, leukocytosis \> 12 G/L or leukopenia \< 4 G/L, purulent tracheal secretions. VAP will be confirmed when these criteria are associated to microbiological confirmation, with at least 105 CFU/mL in endotracheal aspirates or broncho-alveolar lavage.
Time frame: 28 days
Duration of mechanical ventilation
Duration of mechanical ventilation during ICU stay, censored at day 28
Time frame: 28 days
ICU length of stay
ICU length of stay, censored at day 28
Time frame: 28 days
Mortality
Mortality censored at day 28
Time frame: 28 days
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