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Completed

NCT Number: NCT06729476

The Effect of Uroshield on Sputum-specimen Bacterial Growth

The investigators retrospectively register the conduct of this study after its completion.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Mechanically ventilated patients

Exclusion criteria

Less than 18 years of age, pregnant women

Treatment and study plan

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.

Primary outcomes

  1. Sputum-specimen bacterial growth

    Time frame: six months

    Sputum specimen collection at day 0 and then every third day for 15 days.

  2. Growth of multidrug resistant organisms from sputum cultures

    Time frame: six months

    Isolation of sputum specimens collected at day 0 and then every third day for 15 days.

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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