Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure

Study Overview
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Brief Summary
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Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflations and overinflations frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions. The aim of this study is to determine the efficiency of Mallinckrodt electronic device (Mallinckrodt electronic cuff pressure controller, VBM Medizintechnik GmbH, Sulz aN) in continuous control of tracheal cuff pressure.

Official Title
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Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure

Conditions
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Critical Illness

Intervention / Treatment
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* Device: Continuous control of Pcuff followed by manual control
* 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 high volume / low pressure PVC-cuffed tracheal tube Predicted duration of mechanical ventilation > or = 48h Age > or = 18 years signed informed consent Exclusion Criteria: Contraindication for semirecumbent position Contraindication for enteral nutrition Pregnancy refuse to participate to the study

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Continuous control of Pcuff followed by manual control<br>Patients receive continuous control of cuff pressure with Mallinckrodt electronic device for 24h, followed by discontinuous control (every 8 hours) with a manual manometer for 24h. | Device: Continuous control of Pcuff followed by manual control<br>* continuous control of tracheal cuff pressure using an electronic device for 24 h followed by manual control of cuff pressure using a manometer<br>|
| Other: 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>* 24 h of manual control using a manometer followed by 24 h of continuous control using an electronic 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 2 24-h periods (with or without Mallinckrodt device) | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Mallinckrodt electronic device on microaspiration of gastric contents, documented by pepsin levels in tracheal aspirates | Pepsin will be quantitatively measured in tracheal aspirates of all patients during the 2 24-h periods (with or without Mallinckrodt device) | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tracheal cuff pressure, continuous control, microaspiration