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

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ClinicalTrials.gov Identifier: NCT01555229
Recruitment Status : Terminated (Enrolment difficulties)
First Posted : March 15, 2012
Last Update Posted : September 17, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Complication Device: Intermittent subglottic secretion drainage Device: Continuous subglottic secretion drainage Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : August 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: Intermittent drainage
Intermittent subglottic secretion drainage at -100 mmHg during 8 sec every 15 seconds.
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.

Active Comparator: Continuous drainage.
Continuous subglottic secretion drainage at -20 mmHg.
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.




Primary Outcome Measures :
  1. 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) ]
    • stage 0: no lesion
    • stage 1: erythema
    • stage 2 : oedema
    • stage 3 : ulceration
    • stage 4 : necrosis


Secondary Outcome Measures :
  1. Volume of daily secretions [ Time Frame: During intubation ]
  2. Occurrence of difficulties or impossibilities of secretion drainage [ Time Frame: During intubation ]
  3. Occurrence of ventilator-associated pneumonia [ Time Frame: During intubation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555229


Locations
France
Service de Réanimation Chirurgicale, Hôpital de Pontchaillou
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
Study Chair: Bruno Laviolle, MD, PhD Rennes University Hospital
Principal Investigator: Philippe Seguin, MD, PhD Rennes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01555229     History of Changes
Other Study ID Numbers: 2010-A00912-37
CIC0203/124 ( Other Identifier: RennesClinicalSearchCenter )
LOC/09-05 ( Other Identifier: Rennes University Hospital )
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: April 2015

Keywords provided by Rennes University Hospital:
Secretion drainage
Ventilator-associated pneumonia
Tracheal fibroscopy