Mechanical Ventilation Complication, Tracheal Intubation Morbidity
Conditions
Keywords
Mechanical ventilation, Intubation, Cuff pressure, Microaspiration
Brief summary
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
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.
Interventions
DEVICEPneumatic device, cylindrical or tapered cuff
Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with underinflation or overinflation of cuff pressure | 48 h | Continuous recording of cuff pressure will be performed during 2 24-h periods (with or without the pneumatic device) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of continuous control of cuff pressure on microaspiration of gastric contents | 48 h | Pepsin will be quantitatively measured in tracheal aspirates of all patients during the 2 24-h periods (with or without the pneumatic device) |
| Impact of tracheal-cuff shape on variations in cuff pressure | 48 h | Patients will be intubated with cylindrical or tapered polyurethane cuffed tubes. |
| Impact of tracheal cuff shape on microaspiration of gastric contents | 48 h | Pepsin level in tracheal aspirates will be compared between patients intubated with cylindrical polyurethane cuffed-tubes versus those intubated with tapered polyurethane cuffed-tubes |
Countries
France
Outcome results
None listed