Many studies provide evidence for the benefit of lower respiratory tract surveillance, mostly by culture of endotracheal secretions, to predict bacterial pathogens (especially multi-drugs resistant pathogens) involved in VAP. The DEMETER study (NCT02515617) assessing the medico-economical impact of the subglottic secretions drainage (SSD) provides the opportunity to evaluate the accuracy of the subglottic secretions culture surveillance to predict pathogens involved in VAP (in comparison with the concomitant endotracheal secretions surveillance). These subglottic and tracheal secretions culture surveillance will be masked to the investigators of the DEMETER Study. This ancillary study will be performed in 14 centers participating to the DEMETER study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
420
In each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure
In each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure. In addition, SSD will be realized using a 10 ml syringe at in attending frequency of 2 hours.
CHU André Vésale
Montigny-le-Tilleul, Belgium
CH Annecy Genevois
Annecy, France
Centre Hospitalier Victor Dupouy
Argenteuil, France
Centre Hospitalier Intercommunal des Portes de l'Oise
Beaumont-sur-Oise, France
Chd Vendee
La Roche-sur-Yon, France
CH Docteur Schaffner
Lens, France
CH de Montauban
Montauban, France
Centre Hospitalier Régional d'Orléans
Orléans, France
CHU Pointe à Pitre les Abymes
Pointe à Pitre, France
CHI Poissy Saint Germain
Poissy, France
...and 5 more locations
Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the subglottic secretions culture surveillance.
For each episode of VAP, bacteria involved will be compared with bacteria isolated, previously, into the subglottic secretions. This comparison will be performed by the microbiologist of each center. A bacteria isolated into the subglottic secretions will be considered as the same than the one involved in VAP if these 2 same micro-organisms have the same antibiotics susceptibility. Moreover, for the comparison, the third last subglottic secretions samples, if available, obtained before the VAP occurrence, will be taking account.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Rate of adjudicated VAP in which the bacteria involved have been, previously, detected with the tracheal secretions culture surveillance.
For each episode of VAP, bacteria involved will be compared with bacteria isolated, previously, into the tracheal secretions. This comparison will be performed by the microbiologist of each center. A bacteria isolated into the tracheal secretions will be considered as the same than the one involved in VAP if these 2 same microorganisms have the same antibiotics susceptibility. Moreover, for the comparison, the third last tracheal secretions samples, if available, obtained before the VAP occurrence will be taking account.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Adequate probabilistic antibiotherapy initiated during the study by the investigators in case of adjudicated VAP
Proportion of VAP for whom the probabilistic antibiotherapy used during the trial appeared to be empirically active
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Adequate theoretical probabilistic antibiotherapy with the knowledge of the subglottic culture surveillance
Proportion of adjudicated VAP for whom a theoretical probabilistic antibiotherapy would be empirically active with the knowledge of the results of the subglottic secretions samples obtained more than 3 days before the occurrence of VAP. The theoretical antibiotherapy will be determined by an independent committee unaware of the type of samples evaluated (subglottic or tracheal secretions).
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Adequate theoretical probabilistic antibiotherapy with the knowledge of the tracheal culture surveillance
Proportion of adjudicated VAP for whom a theoretical probabilistic antibiotherapy would be empirically active with the knowledge of the results of the tracheal secretions samples obtained more than 3 days before the occurrence of VAP. The theoretical antibiotherapy will be determined by an independent committee unaware of the type of samples evaluated (subglottic or tracheal secretions).
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
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