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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized, Single Blind Study Comparing the Effect of Intermittent Versus Continuous Subglottic Secretion Drainage on Tracheal Mucosa Damages in Intensive Care Patients Requiring Prolonged Mechanical Ventilation

Conditions
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Mechanical Ventilation Complication

Intervention / Treatment
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* Device: Intermittent subglottic secretion drainage
* Device: Continuous subglottic secretion drainage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent drainage<br>Intermittent subglottic secretion drainage at -100 mmHg during 8 sec every 15 seconds. | Device: Intermittent subglottic secretion drainage<br>* Subglottic secretion drainage is performed using a specially designed endotracheal tube with a separate dorsal lumen that opens immediately above the endotracheal cuff.<br>|
| Active Comparator: Continuous drainage.<br>Continuous subglottic secretion drainage at -20 mmHg. | Device: Continuous subglottic secretion drainage<br>* Subglottic secretion drainage is performed using a specially designed endotracheal tube with a separate dorsal lumen that opens immediately above the endotracheal cuff.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tracheal mucosal damages assessed by tracheal fibroscopy. | stage 0: no lesion stage 1: erythema stage 2 : oedema stage 3 : ulceration stage 4 : necrosis | the primary endpoint will be assessed just before extubation (variable duration depending on patient's status and cause of admission) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secretion drainage, Ventilator-associated pneumonia, Tracheal fibroscopy