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The Effect of Uroshield on Sputum-specimen Bacterial Growth

The Effect of Uroshield on Sputum-specimen Bacterial Growth and Multidrug Resistant Organisms in Mechanically Ventilated Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06729476
Enrollment
48
Registered
2024-12-11
Start date
2016-01-01
Completion date
2017-08-31
Last updated
2024-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanically Ventilated Patients

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

DEVICEUroshield vibrator 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.

Sponsors

Shaare Zedek Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Mechanically ventilated patients

Exclusion criteria

Less than 18 years of age, pregnant women

Design outcomes

Primary

MeasureTime frameDescription
Sputum-specimen bacterial growthsix monthsSputum specimen collection at day 0 and then every third day for 15 days.
Growth of multidrug resistant organisms from sputum culturessix monthsIsolation of sputum specimens collected at day 0 and then every third day for 15 days.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026