Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure
- Conditions
- Critical Illness
- Registration Number
- NCT01965821
- Lead Sponsor
- University Hospital, Lille
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
:
- 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
- Contraindication for semirecumbent position
- Contraindication for enteral nutrition
- Pregnancy
- refuse to participate to the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method percentage of recording time spent with cuff overinflation or underinflation 48 hours Continuous recording of cuff pressure will be performed during 2 24-h periods (with or without Mallinckrodt device)
- Secondary Outcome Measures
Name Time Method Impact of Mallinckrodt electronic device on microaspiration of gastric contents, documented by pepsin levels in tracheal aspirates 48 hours Pepsin will be quantitatively measured in tracheal aspirates of all patients during the 2 24-h periods (with or without Mallinckrodt device)
Trial Locations
- Locations (1)
ICU, Salengro Hospital, University Hospital of Lille
🇫🇷Lille, Nord, France
ICU, Salengro Hospital, University Hospital of Lille🇫🇷Lille, Nord, France