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

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

Study Overview

• Status: Completed
• Conditions: Mechanically Ventilated Patients
• Intervention / Treatment: Device: Uroshield vibrator device

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Mechanically ventilated patients

Exclusion Criteria:

Less than 18 years of age, pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active device study arm; 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.	Device: Uroshield 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.
Placebo Comparator: Sham device control arm; 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.	Device: Uroshield 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Investigators: Study Director: Reuven Friedmann, MD, Shaare Zedek Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: December 8, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 8, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: mechanical ventilation; biofilm; tracheostomy; sputum culture; multi drug resistant organisms
• Other Study ID Numbers: 0278-15-SZMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No