NCT01948635

Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

Detailed description

Microaspiration is the main route for entry of contaminated secretions into the lower respiratory tract of intubated critically ill patients. Tracheobronchial colonization might progress to ventilator-associated pneumonia (VAP) when the quantity and virulence of bacteria are high and when local and general host defenses are weak. Recent in vitro and animal studies suggest that tapered-cuff tracheal tubes could be associated with reduced microaspiration of contaminated secretions and might be helpful in preventing VAP.

Conditions

• Critical Illness
• Mechanical Ventilation Complication
• Ventilator Associated Pneumonia

Interventions

Type	Name	Description
DEVICE	tapered PVC-cuffed tracheal tubes	Patients will be intubated with tapered-shape tracheal tubes
DEVICE	Standard PVC-cuffed tracheal tube	Patients will be intubated with standard PVC cuffed tracheal tubes

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2013-09-23
• Last updated: 2025-12-22

Locations

9 sites across 1 country: France