Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device

Study Overview
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Brief Summary
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Underinflation and overinflation of tracheal cuff are common in intubated patients, including those intubated with polyurethane-cuffed tubes. The aim of this study is to determine the efficiency of a pneumatic device in controlling cuff pressure.

Detailed Description
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Underinflation and overinflation of tracheal cuff are associated with severe complications such as microaspiration of contaminated secretions, and tracheal ischemia. Efficient control of cuff pressure would probably allow reducing complications related to variations in cuff pressure.

Official Title
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Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device

Conditions
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Mechanical Ventilation Complication, Tracheal Intubation Morbidity

Intervention / Treatment
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* Device: Pneumatic device, cylindrical or tapered cuff


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring intubation in the ICU Predicted duration of mechanical ventilation > or = 48h Age > or = 18 years Exclusion Criteria: Contraindication for semirecumbent position Contraindication for enteral nutrition Pregnancy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pneumatic device, tapered cuff<br>Intervention: continuous control of cuff pressure using a pneumatic device, tapered polyurethane cuff | Device: Pneumatic device, cylindrical or tapered cuff<br>* Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff<br>* Other names: Covidien;|
| Experimental: Pneumatic device, cylindrical cuff<br>Continuous control of cuff pressure using a pneumatic device in patients intubated with cylindrical polyurethane cuffed tracheal tubes | Device: Pneumatic device, cylindrical or tapered cuff<br>* Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff<br>* Other names: Covidien;|
| Active Comparator: Routine care, tapered cuff<br>Routine care of cuff pressure using a manometer, tapered polyurethane cuff | Device: Pneumatic device, cylindrical or tapered cuff<br>* Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff<br>* Other names: Covidien;|
| Active Comparator: Routine care, cylindrical cuff<br>Routine care of cuff pressure using a manometer, cylindrical polyurethane tracheal cuff | Device: Pneumatic device, cylindrical or tapered cuff<br>* Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff<br>* Other names: Covidien;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with underinflation or overinflation of cuff pressure | Continuous recording of cuff pressure will be performed during 2 24-h periods (with or without the pneumatic device) | 48 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of tracheal-cuff shape on variations in cuff pressure | Patients will be intubated with cylindrical or tapered polyurethane cuffed tubes. | 48 h | 
| Impact of continuous control of cuff pressure on microaspiration of gastric contents | Pepsin will be quantitatively measured in tracheal aspirates of all patients during the 2 24-h periods (with or without the pneumatic device) | 48 h | 
| Impact of tracheal cuff shape on microaspiration of gastric contents | Pepsin level in tracheal aspirates will be compared between patients intubated with cylindrical polyurethane cuffed-tubes versus those intubated with tapered polyurethane cuffed-tubes | 48 h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical ventilation, Intubation, Cuff pressure, Microaspiration