Severe Trauma Patient clinical trials

Impact of the Addition of a Device Providing Continuous Pneumatic Regulation of Tube Cuff Pressure to an Overall Strategy Aimed at Preventing Ventilator-associated Pneumonia in the Severe Trauma Patient. A Multicentre, Randomised, Controlled Study.

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.