Ventilator-associated Pneumonia
Conditions
Keywords
Ventilator-associated pneumonia, Subglottic-secretions drainage, Critically ill patients, Cost-utility analysis, Prevention
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.
Interventions
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.
Sponsors
Ministry of Health, France
URC Eco Ile de France
University Hospital, Tours
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
| Incremental cost-effectiveness ratio | 1 year after ICU admission | Incremental cost to gain an additional patient free of adjudicated VAP |
| 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 | — |
| Duration of invasive mechanical ventilation | Until weaning of mechanical ventilation, an expected average of 10 days | — |
Countries
Belgium, France, Guadeloupe, Reunion
Outcome results
None listed