Mechanical Ventilation Complication
Conditions
Keywords
Secretion drainage, Ventilator-associated pneumonia, Tracheal fibroscopy
Brief summary
Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic secretion drainage can be either continuous or intermittent. However, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours.
Detailed description
Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic secretion drainage can be either continuous or intermittent. However, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours. Tracheal mucosa injuries will be assessed by tracheal fibroscopy. Secondary endpoints are the volume of daily secretions suctioned, the occurrence of difficulties or impossibilities of secretion drainage, and the occurrence of ventilator-associated pneumonia.
Interventions
DEVICEIntermittent subglottic secretion drainage
Subglottic secretion drainage is performed using a specially designed endotracheal tube with a separate dorsal lumen that opens immediately above the endotracheal cuff.
DEVICEContinuous subglottic secretion drainage
Subglottic secretion drainage is performed using a specially designed endotracheal tube with a separate dorsal lumen that opens immediately above the endotracheal cuff.
Sponsors
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult aged 18 years or more * Patients hospitalized in intensive care unit * Patients requiring endotracheal tube with an expected mechanical ventilation duration of more than 24 hours
Exclusion criteria
* Pregnant or breast-feeding women * Previous known tracheal lesions * Persons deprived of freedom
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tracheal mucosal damages assessed by tracheal fibroscopy. | the primary endpoint will be assessed just before extubation (variable duration depending on patient's status and cause of admission) | * stage 0: no lesion * stage 1: erythema * stage 2 : oedema * stage 3 : ulceration * stage 4 : necrosis |
Secondary
| Measure | Time frame |
|---|---|
| Volume of daily secretions | During intubation |
| Occurrence of difficulties or impossibilities of secretion drainage | During intubation |
| Occurrence of ventilator-associated pneumonia | During intubation |
Countries
France
Outcome results
None listed