The Effect of Uroshield on Sputum-specimen Bacterial Growth

Not Applicable

Completed

• Conditions: Mechanically Ventilated Patients

• Registration Number: NCT06729476
• Lead Sponsor: Shaare Zedek Medical Center

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-08-31
• Study Completion: 2017-08-31
• Status Verified: 2024-12
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-08
• Last Update Submitted: 2024-12-08
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Mechanically ventilated patients

Exclusion Criteria

Less than 18 years of age, pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.