Silver-Coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP) (NASCENT)

January 14, 2017 updated by: C. R. Bard

Multi-center Clinical Trial of the Bard Silver-coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP)

The purpose of this study is to determine if the use of a silver-coated endotracheal tube (ETT) can reduce the incidence and/or delay the time of onset of VAP when compared to a non silver-coated ETT in patients who have been mechanically ventilated for >= 24 hours.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nosocomial pneumonia is the leading cause of death from hospital-acquired infections.Ventilator associated pneumonia (VAP) develops in a significant percentage of patients who have been ventilated for at least 48 hours, and is associated with high morbidity, mortality,and financial costs. Silver is a well-characterized antimicrobial agent, and is the active agent in multiple medical products used to reduce or control infection. Bard has developed a proprietary antimicrobial ETT, manufactured with a hydrophilic coating containing a fine dispersion of silver salts.

This study compare the incidence and time to onset of VAP in patients intubated for >=24 hours with a proprietary silver-coated ETT versus those intubated for >= 24 hours with a standard non-coated ETT.

Study Type

Interventional

Enrollment (Actual)

2003

Phase

  • Phase 3

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

  • United States
    • California
      • San Diego, California, United States, 92103
        • University of California, San Diego
    • Illinois
      • Oak Park, Illinois, United States, 60302
        • West Suburban Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic & Foundation
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • St. John's Mercy Medical Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Audie Murphy VA Medical Center & University Hospital

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 > 18 years
  • expected to be intubated for at least 24 hours
  • able to sign Informed Consent

Exclusion Criteria:

  • symptoms of bronchiectasis
  • severe hemoptysis
  • history of cystic fibrosis
  • intubated > 12 hours within previous 30 days
  • pregnancy
  • participating in a competing trial

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: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
silver salts coated endotracheal tube
Device: silver salts coated endotracheal tube
intubation with silver coated tube
Other Names:
  • Agento
Placebo Comparator: 2
uncoated endotracheal tube
Device: uncoated endotracheal tube
intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of microbiologically-confirmed VAP (mVAP), as determined by quantitative culture of bronchoalveolar lavage fluid, in subjects intubated for >=24 hours.
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
time to onset of mVAP in subjects intubated for >=24 hours
Time Frame: 30 days
30 days
incidence of clinical VAP in subjects intubed for >=24 hours
Time Frame: 30 days
30 days
duration of intubation
Time Frame: unlimited
unlimited
mortality
Time Frame: unlimited
unlimited
antibiotic usage
Time Frame: unlimited
unlimited
length of stay
Time Frame: unlimited
unlimited

Collaborators and Investigators

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

Sponsor

C. R. Bard

Investigators

  • Principal Investigator: Marin H Kollef, MD, Barnes Jewish Hospital, St. Louis, MO

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

November 1, 2002

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 14, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5003A

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.

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