Clinical trial NCT01555229: Effect of Intermittent Versus Continuous Subglottic Secretion Drainage on Tracheal Mucosa Damages
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Mechanical Ventilation Complication
Keywords: Secretion drainage
Ventilator-associated pneumonia
Tracheal fibroscopy
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tracheal mucosal damages assessed by tracheal fibroscopy.
timeFrame: the primary endpoint will be assessed just before extubation (variable duration depending on patient's status and cause of admission)
Secondary outcomes:
measure: Volume of daily secretions
timeFrame: During intubation
measure: Occurrence of difficulties or impossibilities of secretion drainage
timeFrame: During intubation
measure: Occurrence of ventilator-associated pneumonia
timeFrame: During intubation
Other outcomes:
Locations:
city: Rennes
country: France
facility: Service de Réanimation Chirurgicale, Hôpital de Pontchaillou
Study officials:
affiliation: Rennes University Hospital
name: Bruno Laviolle, MD, PhD
role: STUDY_CHAIR
affiliation: Rennes University Hospital
name: Philippe Seguin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seguin P, Perrichet H, Pabic EL, Launey Y, Tiercin M, Corre R, Brinchault G, Laviolle B. Effect of Continuous versus Intermittent Subglottic Suctioning on Tracheal Mucosa by the Mallinckrodt TaperGuard Evac Oral Tracheal Tube in Intensive Care Unit Ventilated Patients: A Prospective Randomized Study. Indian J Crit Care Med. 2018 Jan;22(1):1-4. doi: 10.4103/ijccm.IJCCM_350_17.