Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients

Study Overview
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Brief Summary
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We hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

Detailed Description
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Randomized controlled open label study, performed in a 10-bed ICU. All patients intubated with a PVC-cuffed tracheal tube and receiving enteral nutrition who require at least 48 h of mechanical ventilation are eligible. Patients receive continuous control of cuff pressure using a pneumatic device (intervention group) or manual control using a manometer (control group). Target cuff pressure is 25 cmH2O. In all patients, pepsin is measured in tracheal aspirate during a 48-h period after inclusion, as proxy for gastric content aspiration. In addition tracheobronchial colonization and ventilator associated pneumonia rates will be compared between the two groups.

Official Title
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Phase 4 Study of Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients

Conditions
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Critically Ill

Intervention / Treatment
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* Device: Continuous control of cuff pressure
* Device: Manual control of cuff pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > or = 18 years tracheal intubation using a polyvinylchloride tube predictible duration of mechanical ventilation > 48 h enteral nutrition Exclusion Criteria: refuse to participate to the study no informed consent contra-indication for semirecumbment 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: Continuous control<br>Continuous control of cuff pressure using a pneumatic device | Device: Continuous control of cuff pressure<br>* Continuous control of cuff pressure using a pneumatic device (Nosten, Leved, France)<br>* Other names: Automatic control of cuff pressure (Rusch, Kernen, Germany);|
| Active Comparator: Manual control<br>Manual control of cuff pressure is a routine practice in ICU patients | Device: Manual control of cuff pressure<br>* Manual control of cuff pressure is a routine practice in ICU patients<br>* Other names: Manual manometer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pepsin level in tracheal aspirate |  | 48 h after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-associated pneumonia, tracheobronchial colonization, tracheal ischemic lesions |  | day 28 after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cuff pressure, microaspiration, pepsin, VAP, Mechanical ventilation