NCT01082666

Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients

Phase 4 Study of Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

We hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

Detailed description

Randomized controlled open label study, performed in a 10-bed ICU. All patients intubated with a PVC-cuffed tracheal tube and receiving enteral nutrition who require at least 48 h of mechanical ventilation are eligible. Patients receive continuous control of cuff pressure using a pneumatic device (intervention group) or manual control using a manometer (control group). Target cuff pressure is 25 cmH2O. In all patients, pepsin is measured in tracheal aspirate during a 48-h period after inclusion, as proxy for gastric content aspiration. In addition tracheobronchial colonization and ventilator associated pneumonia rates will be compared between the two groups.

Conditions

• Critically Ill

Interventions

Type	Name	Description
DEVICE	Continuous control of cuff pressure	Continuous control of cuff pressure using a pneumatic device (Nosten, Leved, France)
DEVICE	Manual control of cuff pressure	Manual control of cuff pressure is a routine practice in ICU patients

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-08-01
• Completion: 2010-12-01
• First posted: 2010-03-08
• Last updated: 2015-06-18

Locations

1 site across 1 country: France