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.

Study Overview
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Brief Summary
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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.

Conditions
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Ventilation-associated Pneumonia, Severe Trauma Patient

Intervention / Treatment
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* Device: NOSTEN


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NOSTEN|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients having developed VAP at D28 in intensive care according to the ATS definition |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients having developed VAP in ICU according to the ATS definition |  | max 60 days | 
| 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 | 
| Number of antibiotic free days |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical care, Trauma patients