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Completed

NCT Number: NCT01948635

Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units

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

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Key information

Conditions

Critical Illness Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Mechanical Ventilation Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Ventilator Associated Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICU, Salengro Hospital, University Hospital of Lille, Lille, Nord, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tapered PVC-cuffed tracheal tubes

Device

Patients will be intubated with tapered-shape tracheal tubes

Standard PVC-cuffed tracheal tube

Device

Patients will be intubated with standard PVC cuffed tracheal tubes

Primary outcomes

  1. Microaspiration of gastric contents

    Time frame: 48 hours after randomization

    Mesuerment of pepsin level in tracheal aspirate will be used to quantify microaspiration of gastric contents

Secondary outcomes

  1. Microaspiration of oropharyngeal secretions

    Time frame: 48 h after randomization

    amylase level on tracheal aspirate would allow to quantify microaspiration of oropharyngeal secretions

  2. Tracheobronchial colonization

    Time frame: 28 days after randomization

  3. Ventilator-associated pneumonia

    Time frame: 28 days after randomization

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: BestCuff

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 23, 2013
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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