Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation

Centre Hospitalier Departemental Vendee

Status: Completed

Conditions: Ventilator-associated Pneumonia

Treatments: Device: Endotracheal tubes not allowing SSD; Device: Endotracheal tubes allowing SSD

Study type: Interventional

Funder types: Other

Identifiers

NCT02583308

CHD 053-15

Details and patient eligibility

About

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

Enrollment: 896 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Intensive Care Unit 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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896 participants in 2 patient groups

Period with endotracheal tubes not allowing SSD

Active Comparator group

Description:

During this period of the DEMETER study (NCT02515617), patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions

Treatment:

Device: Endotracheal tubes not allowing SSD

Period with endotracheal tubes allowing SSD

Experimental group

Description:

During this period of the DEMETER study (NCT02515617), patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage

Treatment:

Device: Endotracheal tubes allowing SSD