Coated Endotracheal Tube and Mucus Shaver to Prevent Hospital-Acquired Infections

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00341354
First received: June 19, 2006
Last updated: September 7, 2007
Last verified: September 2007
  Purpose

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 and effective in preventing hospital-acquired infections in patients who require prolonged mechanical ventilation in an intensive care unit (ICU).

Pneumonia is the most frequent hospital-acquired infection in the ICU; its development is likely related to the use of a breathing tube. The tube is placed in the patient's trachea (windpipe) to assist breathing during and after an operation. Currently, breathing tubes in intubated patients are cleaned with a suction catheter that draws out secretions that accumulate in the tube. This method does not clean the tube completely, however, and within a few hours after the breathing tube is placed, bacteria may begin to grow inside the tube. Over time, as the patient breathes in and out through the tube, the bacteria may break free and enter the lungs, possibly causing pneumonia. In addition, the growth of bacteria in the tube decreases the size of the airway passage, making it more difficult to keep air moving in and out of the lungs.

Previous studies have shown that breathing tubes coated with silver-sulfadiazine prevented bacterial growth in the patient's airways and that use of the Mucus Shaver prevented accumulation of secretions in the lumen of the breathing tube, keeping the tube open. This study will determine if use of the coated tube and Mucus Shaver in patients requiring prolonged mechanical ventilation is safe and if it can reduce bacterial growth, the length of intubation and mechanical ventilation, the occurrence of pneumonia and the length of time in ICU and hospital.

Patients at San Gerardo Hospital who are 18 and older, who expect to have a breathing tube in place for more than 48 hours, and who are not allergic to silver-sulfadiazine may be eligible for this study.

Participants are randomly assigned to have either a standard breathing tube and standard cleaning or a coated tube cleaned with a Mucus Shaver. At intubation, a sample of secretions is collected from the mouth, the lumen of the breathing tube, and the airways. The lumen of the breathing tube is then cultured every day. When the tube is removed, or on the eighth day of intubation, a sample of secretions is collected from the mouth, the lumen of the breathing tube, and the airways. After the tube is removed, it is examined for biological and microscopic analysis.


Condition Intervention Phase
Infection
Behavioral: Prolonged Mechanical Ventilation
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Evaluation of Silver-Sulfadiazine Tracheal Tubes / Mucus Shaver in Intubated Patients Expected to Have a Prolonged Mechanical Ventilation

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 24
Study Start Date: January 2006
Estimated Study Completion Date: September 2007
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 ventilator. In two phase I/II clinical studies, we tested endotracheal tubes (ETT), internally coated with bacteriocidal agents, and the Mucus Shaver, which removes material from the inside of the endotracheal tube. We showed 1) no adverse events, 2) that coating the inner wall of the ETT with silver-sulfadiazine significantly reduced bacterial colonization of the ETT; and 3) the Mucus Shaver cleans the lumen, leaving the entire endotracheal tube free of secretions, and maintains the lumen diameter. In this study, to evaluate the safety and effectiveness of the Mucus Shaver with the coated ETT, we propose to conduct a randomized trial in intubated patients on prolonged mechanical ventilation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Males and females greater than 18 years old;
    2. Patients who are expected to be intubated and mechanically ventilated for greater than 48 hours;
    3. Patients who require an endotracheal tube with an internal diameter of 7.5 mm or 8.0 mm.

EXCLUSION CRITERIA:

  1. Males and females less than 18 years old;
  2. Patients who are expected to be intubated for less than 48 hours;
  3. Patients who are allergic to silver-sulfadiazine;
  4. Patients who require an internal diameter of an endotracheal tube less than 7.5 mm or greater than 8.0 mm;
  5. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00341354

Locations
Italy
Hospital San Gerardo di Monza, University of Bicocca Monza
Milan, Italy
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00341354     History of Changes
Other Study ID Numbers: 999906087, 06-H-N087
Study First Received: June 19, 2006
Last Updated: September 7, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Pneumonia
Bacterial Infection
Nosocomial Infection
Trachea
Biofilm
Mucus Shaver

ClinicalTrials.gov processed this record on April 21, 2014