Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341354
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Coated Endotracheal Tube and Mucus Shaver to Prevent Hospital-Acquired Infections
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of Silver-Sulfadiazine Tracheal Tubes Mucus Shaver in Intubated Patients Expected to Have a Prolonged Mechanical Ventilation
Status:
COMPLETED
Status Verified Date:
2007-09-06
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:
None
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 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 patients 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 patients 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
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 patients 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 patients 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
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 III 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
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-H-N087 | None | None | None |