Effect of Intermittent Versus Continuous Subglottic Secretion Drainage on Tracheal Mucosa Damages (ASPIRE)

Rennes University Hospital

Status and phase: Terminated; Phase 3

Conditions: Mechanical Ventilation Complication

Treatments: Device: Intermittent subglottic secretion drainage; Device: Continuous subglottic secretion drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT01555229

LOC/09-05 (Other Identifier)

2010-A00912-37

CIC0203/124 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Intermittent drainage

Experimental group

Description:

Intermittent subglottic secretion drainage at -100 mmHg during 8 sec every 15 seconds.

Treatment:

Device: Intermittent subglottic secretion drainage

Continuous drainage.

Active Comparator group

Description:

Continuous subglottic secretion drainage at -20 mmHg.

Treatment:

Device: Continuous subglottic secretion drainage