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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| University Hospital, Tours | OTHER |
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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
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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 Drainage |
|
| 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 |
|---|---|---|
| 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. | Until weaning of mechanical ventilation, an expected average of 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 |
|---|---|---|---|
| 23188467 | Background | Brusselaers N, Labeau S, Vogelaers D, Blot S. Value of lower respiratory tract surveillance cultures to predict bacterial pathogens in ventilator-associated pneumonia: systematic review and diagnostic test accuracy meta-analysis. Intensive Care Med. 2013 Mar;39(3):365-75. doi: 10.1007/s00134-012-2759-x. Epub 2012 Nov 28. |
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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 |
| 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 | 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). | 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). | 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 | 85170 | 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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