Ventilation-associated pneumonia is the main site of healthcare-associated infections in the severe trauma patient, with a mean incidence rate of 35%. Ventilator-associated pneumonia increases morbi-mortality, length of stay in intensive care and overall management costs. As was recalled by the jury of the 2008 SFAR-SRLF consensus conference on the prevention of nosocomial infections contracted in intensive care, success in this preventive endeavour depends on a number of measures: orotracheal intubation route, maintaining tube cuff pressure between 25 and 30 cm H2O, maintaining a semi-seated position ≥30°, nasal and oropharyngeal care at regular intervals, striving to avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for early weaning from ventilation. Devices ensuring continuous pneumatic control of tube cuff pressure are more efficient in maintaining tracheal balloon pressure than intermittent adjustments using a hand-held manometer. In one study, these devices clearly facilitated diminution of microaspiration of gastric contents and of ventilator-associated pneumonia incidence density (9.7 vs. 22 VAP/1000 days of mechanical ventilation; p = 0.005). The investigators are putting forward the hypothesis that by adjoining a device providing continuous pneumatic regulation of tube cuff pressure to an overall strategy aimed at ventilator-associated pneumonia prevention (including semi-recumbent position ≥30°, oro-nasal-pharyngeal care at regular intervals and reduced risk exposure) can decrease VAP incidence by 50% in severely traumatised patients whose condition necessitates mechanical ventilation of an expected duration exceeding 48h. Ours is the first large-scale study to evaluate the interest of an innovative technology bundle on decrease of ventilator-associated pneumonia incidence in one of the intensive care populations the most at risk, namely severe trauma patients, a population presently benefiting from the other recommended preventive measures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Enrollment
440
Sigismond LASOCKI
Angers, France
Sébastien PILI FLOURY
Besançon, France
Jean Michel CONSTANTIN
Clermont-Ferrand, France
Catherine PAUGAM
Clichy, France
Belaid BOUHEMAD
Dijon, France
Dominique FALCON
Grenoble, France
Marc LEONE
Marseille, France
Karim ASEHNOUNE
Nantes, France
Carole ICHAI
Nice, France
Jean Yves LEFRANT
Nîmes, France
...and 3 more locations
Proportion of patients having developed VAP at D28 in intensive care according to the ATS definition
Time frame: 28 days
Proportion of patients having developed VAP in ICU according to the ATS definition
Time frame: max 60 days
Proportion of patients having developed early (≤ day 7) or late (> day 7) VAP in ICU according to the ATS definition
Time frame: max 60 days
Time to first episode of VAP diagnosis according to the ATS definition
Time frame: max 60 days
Proportion of patients developing ventilator-associated events (VAE) according to the CDC definition
Time frame: max 60 days
Number of ventilator free days
Time frame: max 60 days
Number of antibiotic free days
Time frame: max 60 days
ICU length-of-stay
Time frame: max 60 days
Proportion of patient who died during their ICU stay
Time frame: max 60 days
Proportion of patients requiring corticosteroids or bronchodilators within 48 hours of tracheal extubation
Time frame: max 60 days
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