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

U

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

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

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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