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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148642
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : January 18, 2017
Information provided by:
C. R. Bard

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Device: silver salts coated endotracheal tube Device: uncoated endotracheal tube Phase 3

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  (Clinical Trial)
Actual Enrollment : 2003 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center Clinical Trial of the Bard Silver-coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP)
Study Start Date : November 2002
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: 1
silver salts coated endotracheal tube
Device: silver salts coated endotracheal tube
intubation with silver coated tube
Other Name: Agento

Placebo Comparator: 2
uncoated endotracheal tube
Device: uncoated endotracheal tube

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. time to onset of mVAP in subjects intubated for >=24 hours [ Time Frame: 30 days ]
  2. incidence of clinical VAP in subjects intubed for >=24 hours [ Time Frame: 30 days ]
  3. duration of intubation [ Time Frame: unlimited ]
  4. mortality [ Time Frame: unlimited ]
  5. antibiotic usage [ Time Frame: unlimited ]
  6. length of stay [ Time Frame: unlimited ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00148642

United States, California
University of California, San Diego
San Diego, California, United States, 92103
United States, Illinois
West Suburban Hospital
Oak Park, Illinois, United States, 60302
United States, Minnesota
Mayo Clinic & Foundation
Rochester, Minnesota, United States, 55905
United States, Missouri
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
United States, Texas
Audie Murphy VA Medical Center & University Hospital
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
C. R. Bard
Principal Investigator: Marin H Kollef, MD Barnes Jewish Hospital, St. Louis, MO

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Joan Dulin, CR Bard, Inc Identifier: NCT00148642     History of Changes
Other Study ID Numbers: 5003A
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by C. R. Bard:
ventilator-associated pneumonia
nosocomial pneumonia

Additional relevant MeSH terms:
Respiratory Insufficiency
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury