Viewing Study NCT00148642



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Study NCT ID: NCT00148642
Status: COMPLETED
Last Update Posted: 2017-01-18
First Post: 2005-09-06

Brief Title: Silver-Coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia VAP
Sponsor: C R Bard
Organization: C R Bard

Study Overview

Official Title: Multi-center Clinical Trial of the Bard Silver-coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia VAP
Status: COMPLETED
Status Verified Date: 2017-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: NASCENT
Brief Summary: The purpose of this study is to determine if the use of a silver-coated endotracheal tube ETT can reduce the incidence andor 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 infectionsVentilator 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 mortalityand 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None