Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units
NCT ID: NCT01948635
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
326 participants
INTERVENTIONAL
2014-04-30
2015-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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tapered PVC-cuffed tracheal tubes
Patients in this arm will be intubated with tapered PVC-tracheal tubes
tapered PVC-cuffed tracheal tubes
Patients will be intubated with tapered-shape tracheal tubes
Standard PVC-cuffed tracheal tube
Patients in this arm will be intubated with standard (barrel-shape cuffed) PVC tracheal tubes
Standard PVC-cuffed tracheal tube
Patients will be intubated with standard PVC cuffed tracheal tubes
Interventions
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tapered PVC-cuffed tracheal tubes
Patients will be intubated with tapered-shape tracheal tubes
Standard PVC-cuffed tracheal tube
Patients will be intubated with standard PVC cuffed tracheal tubes
Eligibility Criteria
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Inclusion Criteria
* tracheal intubation
* predictable duration of mechanical ventilation \> 48h
* enteral nutrition
Exclusion Criteria
* refuse to participate to the study
* no informed consent
* contre indication for semirecumbent position
18 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Saad Nseir, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHRU de Lille
Locations
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ICU, Salengro Hospital, University Hospital of Lille
Lille, Nord, France
centre Hospitalier
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
Countries
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References
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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.
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.
Other Identifiers
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2012_45
Identifier Type: -
Identifier Source: org_study_id
2013 A00534 41
Identifier Type: OTHER
Identifier Source: secondary_id
PHRCI_2012
Identifier Type: OTHER
Identifier Source: secondary_id