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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| University Hospital, Tours | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period with endotracheal tubes not allowing SSD | Active Comparator | During this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions |
|
| Period with endotracheal tubes allowing SSD | Experimental | During this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endotracheal tubes not allowing SSD | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of pseudomonas aeruginosa presence in tracheal secretions according to the study group. | Until weaning of mechanical ventilation, an expected average of 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of staphylococcus aureus presence in tracheal secretions according to the study group. | Until weaning of mechanical ventilation, an expected average of 10 days | |
| Cumulative incidence of enterobacteria presence in tracheal secretions according to the study group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Claude LACHERADE, MD | CHD VENDEE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU André Vésale | Montigny-le-Tilleul | 6110 | Belgium | |||
| CH Annecy Genevois |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14647884 | Background | Girou E, Buu-Hoi A, Stephan F, Novara A, Gutmann L, Safar M, Fagon JY. Airway colonisation in long-term mechanically ventilated patients. Effect of semi-recumbent position and continuous subglottic suctioning. Intensive Care Med. 2004 Feb;30(2):225-233. doi: 10.1007/s00134-003-2077-4. Epub 2003 Nov 29. |
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|
| Endotracheal tubes allowing SSD | Device | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Until weaning of mechanical ventilation, an expected average of 10 days |
| Annecy |
| 74374 |
| France |
| Centre Hospitalier Victor Dupouy | Argenteuil | 95100 | France |
| Centre Hospitalier Intercommunal des Portes de l'Oise | Beaumont-sur-Oise | 95260 | France |
| Chd Vendee | La Roche-sur-Yon | 85000 | France |
| CH Docteur Schaffner | Lens | 62307 | France |
| CH de Montauban | Montauban | 82013 | France |
| Centre Hospitalier Régional d'Orléans | Orléans | 45067 | France |
| CHU Pointe-à-Pitre les Abymes | Pointe à Pitre | 97159 | France |
| CHI Poissy Saint Germain | Poissy | 78600 | France |
| Centre Hospitalier René Dubos | Pontoise | 95303 | France |
| CHU La Réunion, site de Saint Denis de la Réunion | Saint-Denis (Réunion) | 97405 | France |
| CH de Saint Nazaire | Saint-Nazaire | 44606 | France |
| CHU de Strasbourg Nouvel Hôpital Civil | Strasbourg | 67000 | France |
| CHU Tours, site Bretonneau | Tours | 37044 | France |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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