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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_20/0925 | Other Identifier | sponsor |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pneumatic device, tapered cuff | Experimental | Intervention: continuous control of cuff pressure using a pneumatic device, tapered polyurethane cuff |
|
| Pneumatic device, cylindrical cuff | Experimental | Continuous control of cuff pressure using a pneumatic device in patients intubated with cylindrical polyurethane cuffed tracheal tubes |
|
| Routine care, tapered cuff | Active Comparator | Routine care of cuff pressure using a manometer, tapered polyurethane cuff |
|
| Routine care, cylindrical cuff | Active Comparator | Routine care of cuff pressure using a manometer, cylindrical polyurethane tracheal cuff |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumatic device, cylindrical or tapered cuff | Device | Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saad NSEIR, MD | CHU de Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICU, Calmette Hospital, CHU de Lille | Lille | Nord | 59037 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24369057 | Derived | Jaillette E, Zerimech F, De Jonckheere J, Makris D, Balduyck M, Durocher A, Duhamel A, Nseir S. Efficiency of a pneumatic device in controlling cuff pressure of polyurethane-cuffed tracheal tubes: a randomized controlled study. BMC Anesthesiol. 2013 Dec 26;13(1):50. doi: 10.1186/1471-2253-13-50. |
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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 |