NCT02515617

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

Drainage of Subglottic Secretions and Prevention of Ventilator-associated Pneumonia in Intensive carE Units: Medico-Economic Study With a Randomized clusTer and crossovER Design: DEMETER Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,577 (actual)
• Sponsor: Centre Hospitalier Departemental Vendee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventilator-associated Pneumonia

Interventions

Type	Name	Description
DEVICE	Endotracheal tubes not allowing SSD	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
DEVICE	Endotracheal tubes allowing SSD	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.

Timeline

• Start date: 2015-11-05
• Primary completion: 2018-11-22
• Completion: 2018-11-22
• First posted: 2015-08-05
• Last updated: 2019-01-15

Locations

25 sites across 4 countries: Belgium, France, Guadeloupe, Reunion