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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-A00431-56 | Other Identifier | ID-RCB number, ANSM |
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We hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.
Randomized controlled open label study, performed in a 10-bed ICU. All patients intubated with a PVC-cuffed tracheal tube and receiving enteral nutrition who require at least 48 h of mechanical ventilation are eligible. Patients receive continuous control of cuff pressure using a pneumatic device (intervention group) or manual control using a manometer (control group). Target cuff pressure is 25 cmH2O.
In all patients, pepsin is measured in tracheal aspirate during a 48-h period after inclusion, as proxy for gastric content aspiration. In addition tracheobronchial colonization and ventilator associated pneumonia rates will be compared between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous control | Experimental | Continuous control of cuff pressure using a pneumatic device |
|
| Manual control | Active Comparator | Manual control of cuff pressure is a routine practice in ICU patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous control of cuff pressure | Device | Continuous control of cuff pressure using a pneumatic device (Nosten, Leved, France) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pepsin level in tracheal aspirate | 48 h after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-associated pneumonia, tracheobronchial colonization, tracheal ischemic lesions | day 28 after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain Durocher, MD | CHRU de Lille | Study Director |
| Malika Balduyck, MD | CHU de Lille | Study Director |
| Farid Zerimech, MD | CHU de Lille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICU, Calmette Hospital, University Hospital of Lille | Lille | Nord | 59037 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21836137 | Result | Nseir S, Zerimech F, Fournier C, Lubret R, Ramon P, Durocher A, Balduyck M. Continuous control of tracheal cuff pressure and microaspiration of gastric contents in critically ill patients. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1041-7. doi: 10.1164/rccm.201104-0630OC. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Manual control of cuff pressure | Device | Manual control of cuff pressure is a routine practice in ICU patients |
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