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

C. R. Bard

Status and phase: Completed; Phase 3

Conditions: Respiratory Failure

Treatments: Device: silver salts coated endotracheal tube; Device: uncoated endotracheal tube

Study type: Interventional

Funder types: Industry

Identifiers

NCT00148642

5003A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,003 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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2,003 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

silver salts coated endotracheal tube

Treatment:

Device: silver salts coated endotracheal tube

2

Placebo Comparator group

Description:

uncoated endotracheal tube

Treatment:

Device: uncoated endotracheal tube