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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00148642

Acronym

NASCENT

Enrollment

2003

Registered

2005-09-08

Start date

2002-11-30

Completion date

2006-03-31

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Keywords

ventilator-associated pneumonia, nosocomial pneumonia

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.

Interventions

DEVICEsilver salts coated endotracheal tube

intubation with silver coated tube

DEVICEuncoated endotracheal tube

intubation

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026