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| ID | Type | Description | Link |
|---|---|---|---|
| 2013 A00534 41 | Other Identifier | ID-RCB number, ANSM | |
| PHRCI_2012 | Other Identifier | PHRC numner, DGOS |
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The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.
Microaspiration is the main route for entry of contaminated secretions into the lower respiratory tract of intubated critically ill patients. Tracheobronchial colonization might progress to ventilator-associated pneumonia (VAP) when the quantity and virulence of bacteria are high and when local and general host defenses are weak.
Recent in vitro and animal studies suggest that tapered-cuff tracheal tubes could be associated with reduced microaspiration of contaminated secretions and might be helpful in preventing VAP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tapered PVC-cuffed tracheal tubes | Experimental | Patients in this arm will be intubated with tapered PVC-tracheal tubes |
|
| Standard PVC-cuffed tracheal tube | Active Comparator | Patients in this arm will be intubated with standard (barrel-shape cuffed) PVC tracheal tubes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tapered PVC-cuffed tracheal tubes | Device | Patients will be intubated with tapered-shape tracheal tubes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microaspiration of gastric contents | Mesuerment of pepsin level in tracheal aspirate will be used to quantify microaspiration of gastric contents | 48 hours after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Microaspiration of oropharyngeal secretions | amylase level on tracheal aspirate would allow to quantify microaspiration of oropharyngeal secretions | 48 h after randomization |
| Tracheobronchial colonization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saad Nseir, MD, PhD | CHRU de Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICU, Salengro Hospital, University Hospital of Lille | Lille | Nord | 59035 | France | ||
| centre Hospitalier |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26407612 | Background | Jaillette E, Brunin G, Girault C, Zerimech F, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Robriquet L, Tamion F, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S. Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial. Trials. 2015 Sep 25;16:429. doi: 10.1186/s13063-015-0955-z. | |
| 28303301 |
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| Standard PVC-cuffed tracheal tube | Device | Patients will be intubated with standard PVC cuffed tracheal tubes |
|
| 28 days after randomization |
| Ventilator-associated pneumonia | 28 days after randomization |
| Boulogne-sur-Mer |
| France |
| Centre Hospitalier | Dunkirk | France |
| Centre Hospitalier | Lens | France |
| Centre Hospitalier St Philibert | Lomme | France |
| Centre hospitalier | Roubaix | France |
| Centre Hospitalier Universitaire | Rouen | France |
| Centre Hospitalie | Tourcoing | France |
| Centre Hospitalier | Valenciennes | France |
| Result |
| Jaillette E, Girault C, Brunin G, Zerimech F, Behal H, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Labreuche J, Robriquet L, Tamion F, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S; BestCuff Study Group and the BoReal Network. Impact of tapered-cuff tracheal tube on microaspiration of gastric contents in intubated critically ill patients: a multicenter cluster-randomized cross-over controlled trial. Intensive Care Med. 2017 Nov;43(11):1562-1571. doi: 10.1007/s00134-017-4736-x. Epub 2017 Mar 16. |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
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