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

Phase 3

Completed

• Conditions: Respiratory Failure
• Interventions: Device: uncoated endotracheal tube; Device: silver salts coated endotracheal tube

• Registration Number: NCT00148642
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2002-11
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-14
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2003

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2	uncoated endotracheal tube	uncoated endotracheal tube
1	silver salts coated endotracheal tube	silver salts coated endotracheal tube

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

West Suburban Hospital; 🇺🇸 Oak Park, Illinois, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

Mayo Clinic & Foundation; 🇺🇸 Rochester, Minnesota, United States

St. John's Mercy Medical Center; 🇺🇸 St. Louis, Missouri, United States

Audie Murphy VA Medical Center & University Hospital; 🇺🇸 San Antonio, Texas, United States