Medico-economic Study of the Subglottic Secretions Drainage in Prevention of Ventilator-associated Pneumonia (DEMETER)

Centre Hospitalier Departemental Vendee2,577 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

2,577

Conditions

Ventilator-associated Pneumonia

Interventions

Endotracheal tubes allowing SSDDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

...and 15 more locations

Outcomes

Primary Outcomes

Incremental cost-utility ratio

Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD implementation

Time frame: 1 year after ICU admission

Secondary Outcomes

Incremental cost-effectiveness ratio

Incremental cost to gain an additional patient free of adjudicated VAP

Time frame: 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

Time frame: 1 year after ICU admission

Incremental cost-effectiveness ratio

Incremental cost to gain an additional life-year

Time frame: 1 year after ICU admission

Budget impact analysis

Time frame: 5 years

Microbiologically-confirmed VAP incidence