Efficiency of a Mechanical Device in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients

Study Overview
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Brief Summary
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Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflation and overinflation frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions.

Detailed Description
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The aim of this study is to determine the efficiency of Pressure easy® device (Smiths medical cuff pressure controller) in continuous control of tracheal cuff pressure.

Official Title
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Efficiency of PressureEasy in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients

Conditions
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Cuff Overinflation, Cuff Underinflation

Intervention / Treatment
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* Device: Pressure easy® device
* Device: Manual control of Pcuff followed by continuous control.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients intubated in the ICU with a polyvinyl chloride (PVC) cuffed tracheal tube. Predicted duration of mechanical ventilation > or = 48h. Age > or = 18 years. Signed informed consent. Exclusion Criteria: Anticipated duration of mechanical ventilation<48h after randomization. Tracheostomized patients. Patients with contraindication for semirecumbent position. Patients participating to another trial that might influence this study results.

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous control of Pcuff followed by manual control<br>Patients receive continuous control of cuff pressure with Pressure easy® device for 24h, followed by discontinuous control (every 4 hours) with a manual manometer for 24 h. | Device: Pressure easy® device<br>* Continuous control of tracheal cuff pressure using a mechanical device for 24h followed by manual control of cuff pressure using a manometer.<br>* Other names: Pressure easy® device (Smiths medical cuff pressure controller);|
| Active Comparator: Manual control of Pcuff followed by continuous control.<br>Patients receive the reverse sequence (manual control followed by continuous control of Pcuff) | Device: Manual control of Pcuff followed by continuous control.<br>* Control 24h with manual control using a manometer followed by 24h of continuous control using a mechanical device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of recording time spent with cuff overinflation or underinflation | Continuous recording of cuff pressure will be performed during two 24-h periods (with or without Pressure easy® device) | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tracheal cuff, cuff overinflation, cuff underinflation