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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOSTEN | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients having developed VAP at D28 in intensive care according to the ATS definition | 28 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sigismond LASOCKI | Angers | 49100 | France | |||
| Sébastien PILI FLOURY |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33727034 | Derived | Marjanovic N, Boisson M, Asehnoune K, Foucrier A, Lasocki S, Ichai C, Leone M, Pottecher J, Lefrant JY, Falcon D, Veber B, Chabanne R, Drevet CM, Pili-Floury S, Dahyot-Fizelier C, Kerforne T, Seguin S, de Keizer J, Frasca D, Guenezan J, Mimoz O; AGATE Study Group. Continuous Pneumatic Regulation of Tracheal Cuff Pressure to Decrease Ventilator-associated Pneumonia in Trauma Patients Who Were Mechanically Ventilated: The AGATE Multicenter Randomized Controlled Study. Chest. 2021 Aug;160(2):499-508. doi: 10.1016/j.chest.2021.03.007. Epub 2021 Mar 13. | |
| 28790042 |
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| 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 |
| Besançon |
| 25030 |
| France |
| Jean Michel CONSTANTIN | Clermont-Ferrand | 63100 | France |
| Catherine PAUGAM | Clichy | 92110 | France |
| Belaid BOUHEMAD | Dijon | 21000 | France |
| Dominique FALCON | Grenoble | 38700 | France |
| Marc LEONE | Marseille | 13915 | France |
| Karim ASEHNOUNE | Nantes | 44000 | France |
| Carole ICHAI | Nice | 06000 | France |
| Jean Yves LEFRANT | Nîmes | 30900 | France |
| Olivier MIMOZ | Poitiers | 86021 | France |
| Benoit VEBER | Rouen | 76031 | France |
| Julien POTTECHER | Strasbourg | 67098 | France |
| Derived |
| Marjanovic N, Frasca D, Asehnoune K, Paugam C, Lasocki S, Ichai C, Lefrant JY, Leone M, Dahyot-Fizelier C, Pottecher J, Falcon D, Veber B, Constantin JM, Seguin S, Guenezan J, Mimoz O; AGATE study group. Multicentre randomised controlled trial to investigate the usefulness of continuous pneumatic regulation of tracheal cuff pressure for reducing ventilator-associated pneumonia in mechanically ventilated severe trauma patients: the AGATE study protocol. BMJ Open. 2017 Aug 7;7(8):e017003. doi: 10.1136/bmjopen-2017-017003. |