Severe Trauma Patient, Ventilation-associated Pneumonia
Conditions
Keywords
Critical care, Trauma patients
Brief summary
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients having a severe trauma as defined by an Injury Severity Score (ISS) \>15, * Aged at least 18 years, * Intubated for less than 15h, * Necessitating recourse to mechanical ventilation for an expected period ≥ 48h, * Participating in a social security scheme or benefiting from such a scheme by means of a third party.
Exclusion criteria
* Patient likely to die over the 48h following admission, * Nasotracheal intubation, * Patient intubated through a tracheal tube with subglottic secretion drainage * Intubation carried out 24h or more after the trauma, * Ventilation with tracheotomy, * Refusal to participate in the research, * Contraindication to the head-up position, * Participation in another research protocol focusing on an anti-infective treatment or on a measure decreasing the risk of infection, * Persons benefiting from reinforced protection or persons deprived of freedom subsequent to a legal or administrative decision, minors under legal protection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients having developed VAP at D28 in intensive care according to the ATS definition | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients having developed early (≤ day 7) or late (> day 7) VAP in ICU according to the ATS definition | max 60 days |
| Time to first episode of VAP diagnosis according to the ATS definition | max 60 days |
| Proportion of patients developing ventilator-associated events (VAE) according to the CDC definition | max 60 days |
| Number of ventilator free days | max 60 days |
| Proportion of patients having developed VAP in ICU according to the ATS definition | max 60 days |
| ICU length-of-stay | max 60 days |
| Proportion of patient who died during their ICU stay | max 60 days |
| Proportion of patients requiring corticosteroids or bronchodilators within 48 hours of tracheal extubation | max 60 days |
| Number of antibiotic free days | max 60 days |
Countries
France