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| ID | Type | Description | Link |
|---|---|---|---|
| 2013 A00225 40 | Other Identifier | ID-RCB number, ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous control of Pcuff followed by manual control | Other | 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. |
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| Manual control of Pcuff followed by continuous control | Other | Patients receive the reverse sequence (manual control followed by continuous control of Pcuff) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous control of Pcuff followed by manual control | Device | continuous control of tracheal cuff pressure using an electronic device for 24 h followed by manual control of cuff pressure using a manometer |
| 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 |
| 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 |
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Inclusion Criteria: :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saad NSEIR, MD | University Hospital of Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICU, Salengro Hospital, University Hospital of Lille | Lille | Nord | 59035 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27704488 | Result | Rouze A, De Jonckheere J, Zerimech F, Labreuche J, Parmentier-Decrucq E, Voisin B, Jaillette E, Maboudou P, Balduyck M, Nseir S. Efficiency of an electronic device in controlling tracheal cuff pressure in critically ill patients: a randomized controlled crossover study. Ann Intensive Care. 2016 Dec;6(1):93. doi: 10.1186/s13613-016-0200-2. Epub 2016 Oct 4. |
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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 Pcuff followed by continuous control | Device | 24 h of manual control using a manometer followed by 24 h of continuous control using an electronic device |
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