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. (AGATE)

Poitiers University Hospital

Status: Completed

Conditions: Ventilation-associated Pneumonia; Severe Trauma Patient

Treatments: Device: NOSTEN

Study type: Interventional

Funder types: Other

Identifiers

NCT02534974

AGATE

Details and patient eligibility

About

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.

Enrollment: 440 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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