Status:
COMPLETED
Coated Endotracheal Tube and Mucus Shaver to Prevent Hospital-Acquired Infections
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study, conducted at the San Gerardo Hospital in Milan, Italy, will examine whether a bacteriocidal-coated endotracheal tube (breathing tube) cleaned with a device called a Mucus Shaver is safe an...
Detailed Description
Pneumonia is the most frequent hospital-acquired infection in the intensive care unit, having a significant mortality, morbidity and cost. It occurs frequently in patients who are intubated and on a v...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Males and females greater than 18 years old;
- Patients who are expected to be intubated and mechanically ventilated for greater than 48 hours;
- Patients who require an endotracheal tube with an internal diameter of 7.5 mm or 8.0 mm.
- EXCLUSION CRITERIA:
- Males and females less than 18 years old;
- Patients who are expected to be intubated for less than 48 hours;
- Patients who are allergic to silver-sulfadiazine;
- Patients who require an internal diameter of an endotracheal tube less than 7.5 mm or greater than 8.0 mm;
- Patients who do not tolerate disconnection from the ventilator:
- Hemodynamically unstable;
- Severe ARDS: PaO2/FiO2 less than or equal to 200 at PEEP less than or equal to 5 cmH20.
Exclusion
Key Trial Info
Start Date :
January 27 2006
Trial Type :
INTERVENTIONAL
End Date :
September 6 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00341354
Start Date
January 27 2006
End Date
September 6 2007
Last Update
July 2 2017
Active Locations (1)
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1
Hospital San Gerardo di Monza, University of Bicocca Monza
Milan, Italy