Mechanically Ventilated Patients
Conditions
Keywords
tracheostomy, mechanical ventilation, biofilm, sputum culture, multi drug resistant organisms
Brief summary
The investigators retrospectively register the conduct of this study after its completion.
Detailed description
Background: Ventilator-associated pneumonia is a frequent complication of mechanical ventilation, caused by bacterial proliferation and biofilm formation on endotracheal tubes. The UROSHIELDTM is a small device that generates low-energy surface acoustic waves, which transmit energy to the endotracheal tube through a thin cable attached to the tube. Laboratory studies using catheterized urinary tract models have shown a significant reduction in microbial colonization and reduced development of antimicrobial resistance in UROSHIELDTM device treated individuals. Purpose: To evaluate the impact of a UROSHIELDTM device, adapted for endotracheal tube diameter, on the development of positive sputum cultures in intubated patients. Methods: The study was prospective, double-blind, interventional and randomized. Included were newly intubated patients, who were randomized at a rate of 1:1 by a physician not involved in the study. Patients, treating staff and study investigators were blinded to whether the patients received true or sham devices. Sputum cultures were taken at baseline and every three days for 15 days.
Interventions
UROSHIELDTM is a small device that generates low-energy surface acoustic waves, which transmit energy to the endotracheal tube through a thin cable attached to the tube. Laboratory studies using catheterized urinary tract models have shown a significant reduction in microbial colonization and reduced development of antimicrobial resistance in UROSHIELDTM device treated individuals.
Sponsors
Study design
Eligibility
Inclusion criteria
Mechanically ventilated patients
Exclusion criteria
Less than 18 years of age, pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sputum-specimen bacterial growth | six months | Sputum specimen collection at day 0 and then every third day for 15 days. |
| Growth of multidrug resistant organisms from sputum cultures | six months | Isolation of sputum specimens collected at day 0 and then every third day for 15 days. |