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

Phase 3

Terminated

• Conditions: Mechanical Ventilation Complication
• Interventions: Device: Intermittent subglottic secretion drainage; Device: Continuous subglottic secretion drainage

• Registration Number: NCT01555229
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2011-07-01
• Study Start: 2011-08
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-15
• Status Verified: 2015-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-16
• Last Update Posted: 2015-09-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent drainage	Intermittent subglottic secretion drainage	Intermittent subglottic secretion drainage at -100 mmHg during 8 sec every 15 seconds.
Continuous drainage.	Continuous subglottic secretion drainage	Continuous subglottic secretion drainage at -20 mmHg.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Volume of daily secretions	During intubation
Occurrence of difficulties or impossibilities of secretion drainage	During intubation
Occurrence of ventilator-associated pneumonia	During intubation

Trial Locations

Locations (1)

Service de Réanimation Chirurgicale, Hôpital de Pontchaillou; 🇫🇷 Rennes, France