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

Mechanical Ventilation Complication Clinical Trial

— ASPIRE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01555229
• Other study ID #: 2010-A00912-37
• Secondary ID: CIC0203/124LOC/0
• Status: Terminated
• Phase: Phase 3
• First received: July 1, 2011
• Last updated: September 16, 2015
• Start date: August 2011
• Est. completion date: September 2015

Study information

• Verified date: April 2015
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

Device:
• Intermittent 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.
• Continuous 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.

Locations

Country	Name	City	State
France	Service de Réanimation Chirurgicale, Hôpital de Pontchaillou	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Volume of daily secretions		During intubation	No
Secondary	Occurrence of difficulties or impossibilities of secretion drainage		During intubation	No
Secondary	Occurrence of ventilator-associated pneumonia		During intubation	No