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

Respiratory Failure Clinical Trial

— NASCENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148642
• Other study ID #: 5003A
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: January 14, 2017
• Start date: November 2002
• Est. completion date: March 2006

Study information

• Verified date: January 2017
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2003
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• silver salts coated endotracheal tube
intubation with silver coated tube
• uncoated endotracheal tube
intubation

Locations

Country	Name	City	State
United States	West Suburban Hospital	Oak Park	Illinois
United States	Mayo Clinic & Foundation	Rochester	Minnesota
United States	Audie Murphy VA Medical Center & University Hospital	San Antonio	Texas
United States	University of California, San Diego	San Diego	California
United States	St. John's Mercy Medical Center	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

References & Publications (1)

Baughman RP, Spencer RE, Kleykamp BO, Rashkin MC, Douthit MM. Ventilator associated pneumonia: quality of nonbronchoscopic bronchoalveolar lavage sample affects diagnostic yield. Eur Respir J. 2000 Dec;16(6):1152-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	time to onset of mVAP in subjects intubated for >=24 hours		30 days
Secondary	incidence of clinical VAP in subjects intubed for >=24 hours		30 days
Secondary	duration of intubation		unlimited
Secondary	mortality		unlimited
Secondary	antibiotic usage		unlimited
Secondary	length of stay		unlimited