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The Effect of Uroshield on Sputum-specimen Bacterial Growth

NCT ID: NCT06729476

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2017-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Mechanically Ventilated Patients

Keywords

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tracheostomy mechanical ventilation biofilm sputum culture multi drug resistant organisms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Uroshield vibrator device

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Uroshield vibrator device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Mechanically ventilated patients

Exclusion Criteria

Less than 18 years of age, pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Reuven Friedmann, MD

Role: STUDY_DIRECTOR

Shaare Zedek Medical Center

Other Identifiers

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0278-15-SZMC

Identifier Type: -

Identifier Source: org_study_id