Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units (BestCuff)

University Hospital, Lille

Status: Completed

Conditions: Ventilator Associated Pneumonia; Mechanical Ventilation Complication; Critical Illness

Treatments: Device: Standard PVC-cuffed tracheal tube; Device: tapered PVC-cuffed tracheal tubes

Study type: Interventional

Funder types: Other

Identifiers

NCT01948635

2012_45

PHRCI_2012 (Other Identifier)

2013 A00534 41 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 326 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > or = 18 years
• tracheal intubation
• predictable duration of mechanical ventilation > 48h
• enteral nutrition

Exclusion criteria

• pregnant women
• refuse to participate to the study
• no informed consent
• contre indication for semirecumbent position

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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326 participants in 2 patient groups

tapered PVC-cuffed tracheal tubes

Experimental group

Description:

Patients in this arm will be intubated with tapered PVC-tracheal tubes

Treatment:

Device: tapered PVC-cuffed tracheal tubes

Standard PVC-cuffed tracheal tube

Active Comparator group

Description:

Patients in this arm will be intubated with standard (barrel-shape cuffed) PVC tracheal tubes

Treatment:

Device: Standard PVC-cuffed tracheal tube