Meta-analysis provide evidence for the benefit of the subglottic secretions drainage (SSD) to reduce the occurrence of Ventilator-Associated Pneumonia (VAP). Nevertheless, the diagnosis of VAP is widely considered as subjective and prone to both false-positive and false negative assignments. In ths way, the impact of SSD remains controversial and its use limited in Intensive Care Units. The DEMETER study assessing the medico-economical impact of the the subglottic secretions drainage (NCT02515617) provides the opportunity to evaluate the dynamics of tracheal colonisation with and without the realisation of SSD. This evaluation would reinforce the results observed during the DEMETER study in considering the adjudicated VAP incidence. This ancillary study will be performed in 14 centers participating to the DEMETER study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
896
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
Cumulative incidence of pseudomonas aeruginosa presence in tracheal secretions according to the study group.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of staphylococcus aureus presence in tracheal secretions according to the study group.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of enterobacteria presence in tracheal secretions according to the study group.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of streptococcus pneumoniae presence in tracheal secretions according to the study group.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of haemophilus influenzae presence in tracheal secretions according to the study group.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of stenotrophomonas maltophilia presence in tracheal secretions according to the study group.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of acinetobacter baumannii presence in tracheal secretions according to the study group.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of other non-fermenting gram negative bacilli presence in tracheal secretions according to the study group.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of pseudomonas aeruginosa presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of staphylococcus aureus presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of enterobacteria presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of streptococcus pneumoniae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of haemophilus influenzae presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of stenotrophomonas maltophilia presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of acinetobacter baumannii presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
Cumulative incidence of other non-fermenting gram negative bacilli presence in subglottic secretions during the period with endotracheal tubes allowing SSD.
Time frame: Until weaning of mechanical ventilation, an expected average of 10 days
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