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

Sponsor

C. R. Bard (Industry)

Overall Status

Completed

CT.gov ID

NCT00148642

Collaborator

(none)

2,003

Enrollment

Locations

Arms

Duration (Months)

400.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Nov 1, 2002

Actual Primary Completion Date :

Mar 1, 2006

Actual Study Completion Date :

Mar 1, 2006

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	San Diego	California	United States	92103
2	West Suburban Hospital	Oak Park	Illinois	United States	60302
3	Mayo Clinic & Foundation	Rochester	Minnesota	United States	55905
4	St. John's Mercy Medical Center	St. Louis	Missouri	United States	63141
5	Audie Murphy VA Medical Center & University Hospital	San Antonio	Texas	United States	78229