NCT02583308

Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation

Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation: an Ancillary Study of the DEMETER Trial (NCT02515617)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 896 (actual)
• Sponsor: Centre Hospitalier Departemental Vendee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Meta-analysis provide evidence for the benefit of the subglottic secretions drainage (SSD) to reduce the occurrence of Ventilator-Associated Pneumonia (VAP). Nevertheless, the diagnosis of VAP is widely considered as subjective and prone to both false-positive and false negative assignments. In ths way, the impact of SSD remains controversial and its use limited in Intensive Care Units. The DEMETER study assessing the medico-economical impact of the the subglottic secretions drainage (NCT02515617) provides the opportunity to evaluate the dynamics of tracheal colonisation with and without the realisation of SSD. This evaluation would reinforce the results observed during the DEMETER study in considering the adjudicated VAP incidence. This ancillary study will be performed in 14 centers participating to the DEMETER study

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: 2015-11-04
• Primary completion: 2017-11-29
• Completion: 2017-11-29
• First posted: 2015-10-22
• Last updated: 2021-03-23

Locations

15 sites across 2 countries: Belgium, France