Medico-economic Study of the Subglottic Secretions Drainage in Prevention of Ventilator-associated Pneumonia (DEMETER)
- Conditions
- Ventilator-associated Pneumonia
- Registration Number
- NCT02515617
- Lead Sponsor
- Centre Hospitalier Departemental Vendee
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2577
- Age over 18 years
- Invasive mechanical ventilation delivered via an endotracheal tube and expected to be required more than 24 hours
- Intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage (SSD) will be available during the SSD period of the trial
- Information delivered
- Previous inclusion in the study
- Patients moribund at the ICU admission
- Pregnant, parturient or breast-feeding woman
- Patient hospitalized without consent and/or deprived of liberty by court's decision
- Patient under guardianship or curators
- Lack of social insurance
- Concomitant inclusion in a trial on VAP prevention
- Patient with no comprehension of the French language
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Incremental cost-utility ratio 1 year after ICU admission Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD implementation
- Secondary Outcome Measures
Name Time Method Ventilator-free days 90 days after the start of invasive mechanical ventilation Budget impact analysis 5 years Microbiologically-confirmed VAP density of incidence 90 days after the start of invasive mechanical ventilation Incremental cost-effectiveness ratio 1 year after ICU admission Incremental cost to gain an additional life-year
Microbiologically-confirmed VAP 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 Duration of invasive mechanical ventilation Until weaning of mechanical ventilation, an expected average of 10 days Hospital length of stay Until discharge from hospital, an expected average of 20 days Post-extubation laryngo-tracheal dyspnea incidence Until weaning of mechanical ventilation,, an expected average of 10 days Infection related Ventilator-associated Conditions incidence 90 days after the start of invasive mechanical ventilation Incremental cost-utility ratio (subgroup analysis) 1 year after ICU admission Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD in considering patients alive at the ICU discharge
Ventilator-associated Conditions density of incidence 90 days after the start of invasive mechanical ventilation ICU length of stay Until discharge from ICU, an expected average of 12 days 90-days mortality 90 days after ICU admission Ventilator-associated Conditions incidence 90 days after the start of invasive mechanical ventilation ICU mortality Until discharge from ICU, an expected average of 12 days 180-days mortality 180 days after ICU admission 1 year mortality 1 year after ICU admission
Trial Locations
- Locations (25)
CHU André Vésale ,
🇧🇪Montigny-le-Tilleul., Belgium
CH Angoulème
🇫🇷Angoulème, France
CH Annecy Genevois
🇫🇷Annecy, France
Centre Hospitalier Victor Dupouy
🇫🇷Argenteuil, France
Centre Hospitalier Intercommunal des Portes de l'Oise
🇫🇷Beaumont-sur-Oise, France
CHU Dijon
🇫🇷Dijon, France
CHD Vendee
🇫🇷La roche sur yon, France
CH Docteur Schaffner
🇫🇷Lens, France
Centre Hospitalier François Quesnay
🇫🇷Mantes la Jolie, France
CHU marseilles, Hôpital Nord
🇫🇷Marseilels, France
Scroll for more (15 remaining)CHU André Vésale ,🇧🇪Montigny-le-Tilleul., Belgium