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Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units (BestCuff)

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ClinicalTrials.gov Identifier: NCT01948635
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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Brief Summary:
The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

Condition or disease Intervention/treatment Phase
Critical Illness Mechanical Ventilation Complication Ventilator Associated Pneumonia Device: tapered PVC-cuffed tracheal tubes Device: Standard PVC-cuffed tracheal tube Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units
Study Start Date : April 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: tapered PVC-cuffed tracheal tubes
Patients in this arm will be intubated with tapered PVC-tracheal tubes
 Device: tapered PVC-cuffed tracheal tubes
Patients will be intubated with tapered-shape tracheal tubes
Active Comparator: Standard PVC-cuffed tracheal tube
Patients in this arm will be intubated with standard (barrel-shape cuffed) PVC tracheal tubes
 Device: Standard PVC-cuffed tracheal tube
Patients will be intubated with standard PVC cuffed tracheal tubes


Outcome Measures
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Primary Outcome Measures :
  1. Microaspiration of gastric contents [ Time Frame: 48 hours after randomization ]
    Mesuerment of pepsin level in tracheal aspirate will be used to quantify microaspiration of gastric contents


Secondary Outcome Measures :
  1. Microaspiration of oropharyngeal secretions [ Time Frame: 48 h after randomization ]
    amylase level on tracheal aspirate would allow to quantify microaspiration of oropharyngeal secretions

  2. Tracheobronchial colonization [ Time Frame: 28 days after randomization ]
  3. Ventilator-associated pneumonia [ Time Frame: 28 days after randomization ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > or = 18 years
  • tracheal intubation
  • predictable duration of mechanical ventilation > 48h
  • enteral nutrition

Exclusion Criteria:

  • pregnant women
  • refuse to participate to the study
  • no informed consent
  • contre indication for semirecumbent position
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948635


Locations
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France
ICU, Salengro Hospital, University Hospital of Lille
Lille, Nord, France, 59035
centre Hospitalier
Boulogne sur mer, France
Centre Hospitalier
Dunkerque, 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
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Saad Nseir, MD, PhD CHRU de Lille
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01948635    
Other Study ID Numbers: 2012_45
2013 A00534 41 ( Other Identifier: ID-RCB number, ANSM )
PHRCI_2012 ( Other Identifier: PHRC numner, DGOS )
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Keywords provided by University Hospital, Lille:
tracheal cuff shape
microaspiration
pepsin
ventilator-associated pneumonia
Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Ventilator-Associated
Critical Illness
Respiratory Tract Infections
Infections
Lung Diseases
 Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Healthcare-Associated Pneumonia
Cross Infection
Iatrogenic Disease