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Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units

Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01948635
Acronym
BestCuff
Enrollment
326
Registered
2013-09-23
Start date
2014-04-30
Completion date
2015-08-31
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Mechanical Ventilation Complication, Ventilator Associated Pneumonia

Keywords

tracheal cuff shape, microaspiration, pepsin, ventilator-associated pneumonia

Brief summary

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

Detailed 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.

Interventions

DEVICEtapered PVC-cuffed tracheal tubes

Patients will be intubated with tapered-shape tracheal tubes

DEVICEStandard PVC-cuffed tracheal tube

Patients will be intubated with standard PVC cuffed tracheal tubes

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Microaspiration of gastric contents48 hours after randomizationMesuerment of pepsin level in tracheal aspirate will be used to quantify microaspiration of gastric contents

Secondary

MeasureTime frameDescription
Microaspiration of oropharyngeal secretions48 h after randomizationamylase level on tracheal aspirate would allow to quantify microaspiration of oropharyngeal secretions
Tracheobronchial colonization28 days after randomization
Ventilator-associated pneumonia28 days after randomization

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026