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

May 3, 2018 updated by: University Hospital, Lille
The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

326

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne sur mer, France
        • Centre Hospitalier
      • Dunkerque, France
        • Centre Hospitalier
      • Lens, France
        • Centre Hospitalier
      • Lomme, France
        • Centre Hospitalier St Philibert
      • Roubaix, France
        • Centre Hospitalier
      • Rouen, France
        • Centre Hospitalier Universitaire
      • Tourcoing, France
        • Centre Hospitalie
      • Valenciennes, France
        • Centre Hospitalier
    • Nord
      • Lille, Nord, France, 59035
        • ICU, Salengro Hospital, University Hospital of Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microaspiration of oropharyngeal secretions
Time Frame: 48 h after randomization
amylase level on tracheal aspirate would allow to quantify microaspiration of oropharyngeal secretions
48 h after randomization
Tracheobronchial colonization
Time Frame: 28 days after randomization
28 days after randomization
Ventilator-associated pneumonia
Time Frame: 28 days after randomization
28 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Saad Nseir, MD, PhD, CHRU de Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 31, 2013

First Submitted That Met QC Criteria

September 18, 2013

First Posted (Estimate)

September 23, 2013

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012_45
  • 2013 A00534 41 (Other Identifier: ID-RCB number, ANSM)
  • PHRCI_2012 (Other Identifier: PHRC numner, DGOS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Critical Illness

Clinical Trials on tapered PVC-cuffed tracheal tubes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe