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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01555229
First received: July 1, 2011
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Mechanical Ventilation Complication
Device: Intermittent subglottic secretion drainage
Device: Continuous subglottic secretion drainage
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 126
Study Start Date: August 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555229

Contacts
Contact: Philippe Seguin, MD, PhD 33-2-9928-9371 philippe.seguin@chu-rennes.fr

Locations
France
Service de Réanimation Chirurgicale, Hôpital de Pontchaillou Recruiting
Rennes, France, 35033
Contact: Philippe Seguin, MD, PhD    33-2-9928-9371    philippe.seguin@chu-rennes.fr   
Principal Investigator: Philippe Seguin, MD, PhD         
Sub-Investigator: Pascale Le Maguet, MD         
Sub-Investigator: Laurène Daviet, MD         
Sub-Investigator: Betty Suprin, MD         
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
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01555229     History of Changes
Other Study ID Numbers: 2010-A00912-37, CIC0203/124, LOC/09-05
Study First Received: July 1, 2011
Last Updated: July 23, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on July 26, 2014