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Completed

NCT Number: NCT00148642

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.

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Key information

Conditions

Respiratory Failure Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of California, San Diego, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

silver salts coated endotracheal tube

Device

intubation with silver coated tube

Other names: Agento

uncoated endotracheal tube

Device

intubation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

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

Acronym: NASCENT

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Sep 8, 2005
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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