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The investigators retrospectively register the conduct of this study after its completion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active device study arm | Active Comparator | Study Procedure: In this study, half of the recruited patients were connected to the UROSHIELD device (study group), while the other half was connected to a similar but inactive sham device (control group). The medical treating team, research team, and the patients themselves were unaware of who received the active device and who was connected to the inactive, sham device. As mentioned, randomization and allocation of devices was performed by a physician not otherwise involved in the conduct of the study or with data processing. |
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| Sham device control arm | Placebo Comparator | Study Procedure: In this study, half of the recruited patients were connected to the UROSHIELD device (study group), while the other half was connected to a similar but inactive sham device (control group). The medical treating team, research team, and the patients themselves were unaware of who received the active device and who was connected to the inactive, sham device. As mentioned, randomization and allocation of devices was performed by a physician not otherwise involved in the conduct of the study or with data processing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uroshield vibrator device | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sputum-specimen bacterial growth | Sputum specimen collection at day 0 and then every third day for 15 days. | six months |
| Growth of multidrug resistant organisms from sputum cultures | Isolation of sputum specimens collected at day 0 and then every third day for 15 days. | six months |
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Inclusion Criteria:
Mechanically ventilated patients
Exclusion Criteria:
Less than 18 years of age, pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Reuven Friedmann, MD | Shaare Zedek Medical Center | Study Director |
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