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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| URC Eco Ile de France | UNKNOWN |
| University Hospital, Tours | OTHER |
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In France, despite the implementation of bundles to prevent Ventilator-Associated Pneumonia (VAP) in the last decades, the VAP incidence remains high above 10 per cent. In the last american recommendations of VAP prevention, the drainage of subglottic secretions (SSD) has been notified among the "basic practices" to prevent VAP. Nevertheless, the diffusion of SSD in ICUs remains limited. This situation is largely due to the initial overcost of the specific endotracheal tubes allowing SSD and to the unavailability of these devices in medical units in which patients are intubated before the ICU admission. So, this pragmatical cluster randomized and cross-over study evaluates the medico-economic impact of the subglottic secretions drainage in addition to VAP prevention bundles in ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period with endotracheal tubes not allowing SSD | Active Comparator | During this period, patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Drainage |
|
| Period with endotracheal tubes allowing SSD | Experimental | During this period, 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 |
|---|---|---|
| Incremental cost-utility ratio | Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD implementation | 1 year after ICU admission |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental cost-effectiveness ratio | Incremental cost to gain an additional patient free of adjudicated VAP | 1 year after ICU admission |
| Incremental cost-utility ratio (subgroup analysis) | Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD in considering patients alive at the ICU discharge |
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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 Angoulème |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21478738 | Background | Muscedere J, Rewa O, McKechnie K, Jiang X, Laporta D, Heyland DK. Subglottic secretion drainage for the prevention of ventilator-associated pneumonia: a systematic review and meta-analysis. Crit Care Med. 2011 Aug;39(8):1985-91. doi: 10.1097/CCM.0b013e318218a4d9. | |
| 20522796 | Background | Lacherade JC, De Jonghe B, Guezennec P, Debbat K, Hayon J, Monsel A, Fangio P, Appere de Vecchi C, Ramaut C, Outin H, Bastuji-Garin S. Intermittent subglottic secretion drainage and ventilator-associated pneumonia: a multicenter trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):910-7. doi: 10.1164/rccm.200906-0838OC. Epub 2010 Jun 3. |
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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. |
|
| 1 year after ICU admission |
| Incremental cost-effectiveness ratio | Incremental cost to gain an additional life-year | 1 year after ICU admission |
| Budget impact analysis | 5 years |
| Microbiologically-confirmed VAP incidence | 90 days after the start of invasive mechanical ventilation |
| Microbiologically-confirmed VAP density of incidence | 90 days after the start of invasive mechanical ventilation |
| Defined Daily Dose of antibiotics consumption | Until discharge from ICU, an expected average of 12 days |
| Ventilator-associated Conditions incidence | 90 days after the start of invasive mechanical ventilation |
| Ventilator-associated Conditions density of incidence | 90 days after the start of invasive mechanical ventilation |
| Infection related Ventilator-associated Conditions incidence | 90 days after the start of invasive mechanical ventilation |
| Duration of invasive mechanical ventilation | Until weaning of mechanical ventilation, an expected average of 10 days |
| Ventilator-free days | 90 days after the start of invasive mechanical ventilation |
| ICU length of stay | Until discharge from ICU, an expected average of 12 days |
| Hospital length of stay | Until discharge from hospital, an expected average of 20 days |
| ICU mortality | Until discharge from ICU, an expected average of 12 days |
| 90-days mortality | 90 days after ICU admission |
| 180-days mortality | 180 days after ICU admission |
| 1 year mortality | 1 year after ICU admission |
| Post-extubation laryngo-tracheal dyspnea incidence | Until weaning of mechanical ventilation,, an expected average of 10 days |
| Angoulème |
| 16959 |
| France |
| CH Annecy Genevois | Annecy | 74374 | France |
| Centre Hospitalier Victor Dupouy | Argenteuil | 95100 | France |
| Centre Hospitalier Intercommunal des Portes de l'Oise | Beaumont-sur-Oise | 95260 | France |
| CHU Dijon | Dijon | 21000 | France |
| CHD Vendee | La Roche-sur-Yon | 85000 | France |
| CH Docteur Schaffner | Lens | 62307 | France |
| Centre Hospitalier François Quesnay | Mantes-la-Jolie | 78200 | France |
| CHU marseilles, Hôpital Nord | Marseilels | 13000 | France |
| CH de Montauban | Montauban | 82013 | France |
| CHU Nantes | Nantes | 44000 | France |
| Centre Hospitalier Régional d'Orléans | Orléans | 45067 | France |
| CHI Poissy Saint Germain | Poissy | 78600 | France |
| CHU Poitiers | Poitiers | 86021 | France |
| Centre Hospitalier René Dubos | Pontoise | 95303 | France |
| Hôpital Delafontaine | Saint-Denis | 93200 | France |
| CH de Saint Nazaire | Saint-Nazaire | 44606 | France |
| CHU de Strasbourg Hôpital de Hautepierre | Strasbourg | 67000 | France |
| CHU de Strasbourg Nouvel Hôpital Civil | Strasbourg | 67000 | France |
| CHU Tours, site Bretonneau | Tours | 37044 | France |
| CHU Tours, site Trousseau | Tours | France |
| CHU Pointe à Pitre les Abymes | Pointe-à-Pitre | 97159 | Guadeloupe |
| CHU La Réunion, site de Saint Denis de la Réunion | Saint-Denis | 97405 | Reunion |
| CHU La Réunion, site de Saint Pierre de la Réunion | Saint-Pierre | 97448 | Reunion |
| 25376073 | Background | Klompas M, Branson R, Eichenwald EC, Greene LR, Howell MD, Lee G, Magill SS, Maragakis LL, Priebe GP, Speck K, Yokoe DS, Berenholtz SM. Strategies to prevent ventilator-associated pneumonia in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Sep;35 Suppl 2:S133-54. doi: 10.1017/s0899823x00193894. No abstract available. |
| 25871807 | Background | Branch-Elliman W, Wright SB, Howell MD. Determining the Ideal Strategy for Ventilator-associated Pneumonia Prevention. Cost-Benefit Analysis. Am J Respir Crit Care Med. 2015 Jul 1;192(1):57-63. doi: 10.1164/rccm.201412-2316OC. |
| 24321315 | Background | Loupec T, Petitpas F, Kalfon P, Mimoz O. Subglottic secretion drainage in prevention of ventilator-associated pneumonia: mind the gap between studies and reality. Crit Care. 2013 Dec 9;17(6):R286. doi: 10.1186/cc13149. No abstract available. |
| 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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