Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units

Conditions
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Critical Illness, Mechanical Ventilation Complication, Ventilator Associated Pneumonia

Intervention / Treatment
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* Device: tapered PVC-cuffed tracheal tubes
* Device: Standard PVC-cuffed tracheal tube


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tapered PVC-cuffed tracheal tubes<br>Patients in this arm will be intubated with tapered PVC-tracheal tubes | Device: tapered PVC-cuffed tracheal tubes<br>* Patients will be intubated with tapered-shape tracheal tubes<br>|
| Active Comparator: Standard PVC-cuffed tracheal tube<br>Patients in this arm will be intubated with standard (barrel-shape cuffed) PVC tracheal tubes | Device: Standard PVC-cuffed tracheal tube<br>* Patients will be intubated with standard PVC cuffed tracheal tubes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microaspiration of gastric contents | Mesuerment of pepsin level in tracheal aspirate will be used to quantify microaspiration of gastric contents | 48 hours after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microaspiration of oropharyngeal secretions | amylase level on tracheal aspirate would allow to quantify microaspiration of oropharyngeal secretions | 48 h after randomization | 
| Tracheobronchial colonization |  | 28 days after randomization | 
| Ventilator-associated pneumonia |  | 28 days after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tracheal cuff shape, microaspiration, pepsin, ventilator-associated pneumonia