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

This study is currently recruiting participants.
Verified February 2013 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01555229
First received: July 1, 2011
Last updated: February 5, 2013
Last verified: February 2013
History of Changes

July 1, 2011
February 5, 2013
August 2011
June 2013   (final data collection date for primary outcome measure)
Tracheal mucosal damages assessed by tracheal fibroscopy. [ Time Frame: the primary endpoint will be assessed just before extubation (variable duration depending on patient's status and cause of admission) ] [ Designated as safety issue: Yes ]
  • stage 0: no lesion
  • stage 1: erythema
  • stage 2 : oedema
  • stage 3 : ulceration
  • stage 4 : necrosis
Same as current
Complete list of historical versions of study NCT01555229 on ClinicalTrials.gov Archive Site
  • Volume of daily secretions [ Time Frame: During intubation ] [ Designated as safety issue: No ]
  • Occurrence of difficulties or impossibilities of secretion drainage [ Time Frame: During intubation ] [ Designated as safety issue: No ]
  • Occurrence of ventilator-associated pneumonia [ Time Frame: During intubation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Intermittent Versus Continuous Subglottic Secretion Drainage on Tracheal Mucosa Damages
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

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Mechanical Ventilation Complication
  • 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.
  • Device: 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.
  • Experimental: Intermittent drainage
    Intermittent subglottic secretion drainage at -100 mmHg during 8 sec every 15 seconds.
    Intervention: Device: Intermittent subglottic secretion drainage
  • Active Comparator: Continuous drainage.
    Continuous subglottic secretion drainage at -20 mmHg.
    Intervention: Device: Continuous subglottic secretion drainage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
126
September 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Philippe Seguin, MD, PhD 33-2-9928-9371 philippe.seguin@chu-rennes.fr
France
 
NCT01555229
2010-A00912-37, CIC0203/124, LOC/09-05
No
Rennes University Hospital
Rennes University Hospital
Not Provided
Study Chair: Bruno Laviolle, MD, PhD Rennes University Hospital
Principal Investigator: Philippe Seguin, MD, PhD Rennes University Hospital
Rennes University Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP