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

Primary Purpose

Critical Illness, Mechanical Ventilation Complication, Ventilator Associated Pneumonia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tapered PVC-cuffed tracheal tubes
Standard PVC-cuffed tracheal tube
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring tracheal cuff shape, microaspiration, pepsin, ventilator-associated pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ICU, Salengro Hospital, University Hospital of Lille
  • centre Hospitalier
  • Centre Hospitalier
  • Centre Hospitalier
  • Centre Hospitalier St Philibert
  • Centre hospitalier
  • Centre Hospitalier Universitaire
  • Centre Hospitalie
  • Centre Hospitalier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tapered PVC-cuffed tracheal tubes

Standard PVC-cuffed tracheal tube

Arm Description

Patients in this arm will be intubated with tapered PVC-tracheal tubes

Patients in this arm will be intubated with standard (barrel-shape cuffed) PVC tracheal tubes

Outcomes

Primary Outcome Measures

Microaspiration of gastric contents
Mesuerment of pepsin level in tracheal aspirate will be used to quantify microaspiration of gastric contents

Secondary Outcome Measures

Microaspiration of oropharyngeal secretions
amylase level on tracheal aspirate would allow to quantify microaspiration of oropharyngeal secretions
Tracheobronchial colonization
Ventilator-associated pneumonia

Full Information

First Posted
August 31, 2013
Last Updated
May 3, 2018
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT01948635
Brief Title
Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units
Acronym
BestCuff
Official Title
Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Mechanical Ventilation Complication, Ventilator Associated Pneumonia
Keywords
tracheal cuff shape, microaspiration, pepsin, ventilator-associated pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tapered PVC-cuffed tracheal tubes
Arm Type
Experimental
Arm Description
Patients in this arm will be intubated with tapered PVC-tracheal tubes
Arm Title
Standard PVC-cuffed tracheal tube
Arm Type
Active Comparator
Arm Description
Patients in this arm will be intubated with standard (barrel-shape cuffed) PVC tracheal tubes
Intervention Type
Device
Intervention Name(s)
tapered PVC-cuffed tracheal tubes
Intervention Description
Patients will be intubated with tapered-shape tracheal tubes
Intervention Type
Device
Intervention Name(s)
Standard PVC-cuffed tracheal tube
Intervention Description
Patients will be intubated with standard PVC cuffed tracheal tubes
Primary Outcome Measure Information:
Title
Microaspiration of gastric contents
Description
Mesuerment of pepsin level in tracheal aspirate will be used to quantify microaspiration of gastric contents
Time Frame
48 hours after randomization
Secondary Outcome Measure Information:
Title
Microaspiration of oropharyngeal secretions
Description
amylase level on tracheal aspirate would allow to quantify microaspiration of oropharyngeal secretions
Time Frame
48 h after randomization
Title
Tracheobronchial colonization
Time Frame
28 days after randomization
Title
Ventilator-associated pneumonia
Time Frame
28 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saad Nseir, MD, PhD
Organizational Affiliation
CHRU de Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICU, Salengro Hospital, University Hospital of Lille
City
Lille
State/Province
Nord
ZIP/Postal Code
59035
Country
France
Facility Name
centre Hospitalier
City
Boulogne sur mer
Country
France
Facility Name
Centre Hospitalier
City
Dunkerque
Country
France
Facility Name
Centre Hospitalier
City
Lens
Country
France
Facility Name
Centre Hospitalier St Philibert
City
Lomme
Country
France
Facility Name
Centre hospitalier
City
Roubaix
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Rouen
Country
France
Facility Name
Centre Hospitalie
City
Tourcoing
Country
France
Facility Name
Centre Hospitalier
City
Valenciennes
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26407612
Citation
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.
Results Reference
background
PubMed Identifier
28303301
Citation
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.
Results Reference
derived

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Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units

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