Effect of Intermittent Versus Continuous Subglottic Secretion Drainage on Tracheal Mucosa Damages (ASPIRE)
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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 |
- 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
- 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 2013 |
| Estimated Primary Completion Date: | June 2013 (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 |
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| Contact: Philippe Seguin, MD, PhD | 33-2-9928-9371 | philippe.seguin@chu-rennes.fr |
| 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 | |
| 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: | February 5, 2013 |
| 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 May 16, 2013