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

University Hospital, Lille

Status and phase: Completed; Phase 4

Conditions: Critically Ill

Treatments: Device: Continuous control of cuff pressure; Device: Manual control of cuff pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT01082666

2008_53/0919

2009-A00431-56 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > or = 18 years
• tracheal intubation using a polyvinylchloride tube
• predictible duration of mechanical ventilation > 48 h
• enteral nutrition

Exclusion criteria

• refuse to participate to the study
• no informed consent
• contra-indication for semirecumbment position

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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122 participants in 2 patient groups

Continuous control

Experimental group

Description:

Continuous control of cuff pressure using a pneumatic device

Treatment:

Device: Continuous control of cuff pressure

Manual control

Active Comparator group

Description:

Manual control of cuff pressure is a routine practice in ICU patients

Treatment:

Device: Manual control of cuff pressure