Does UROSHIELD® Influence Bacterial Growth On Endotracheal Tubes

Study Overview
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Brief Summary
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The purpose of this study is to examine the effect of UROSHIELD® (a device which generates low energy ultrasound waves) on development of bacterial colonies on endotracheal tubes, in patient receiving mechanical ventilation, and to determine whether this device lowers the rate of bacterial resistance to antibiotics.

Detailed Description
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Ventilator Associated Pneumonia (VAP) is a common complication in patients treated by mechanical ventilation, supposedly related to development of bacterial colonization on the endotracheal tubes. Therefore many devices were designed to address this issue. NanovibronixTM Company developed UROSHIELD® a device which generates low energy ultrasound wave in the nanometer range, and delivers these waves by an actuator which is connected externally to a urinary catheter. It was shown that using UROSHIELD®, there was reduction in development of bacterial colonies, and lower rate of resistance of bacteria to antibiotics. Aim of the study: To examine the effect of UROSHIELD® on development of bacterial colonies on endotracheal tubes, in patient receiving mechanical ventilation, and to determine whether this device lowers the rate of bacterial resistance to antibiotics. Methods: Consecutive patients, with newly begun mechanical ventilation, will be connected to UROSHIELD® within 48 hours. Endotracheal secretions will be collected for culture and antibiotic sensitivity every 3 days for 15 consecutive days or until disconnection from the mechanical ventilation. Half of the devices will be active for the study group; the other half will be sham for the control. The devices will externally look identical and will have a serial number which will remain secret. Primary end point: The time to convert the sputum culture from negative to positive. Secondary end points: The number of positive cultures with virulent bacteria and the rate of development of resistance to antibiotics will also be compared. By statistical analysis the investigators conclude that enrollment of 33 patients into each group will allow significant results to be detected. Should the study group show longer time to convert to positive bacterial culture and/or lower antibiotic resistance, the use of UROSHIELD®, should be examined in a larger study, with reduction of VAP as a primary end point.

Official Title
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Does UROSHIELD® Influence Bacterial Growth On Endotracheal Tubes

Conditions
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Mechanical Ventilation Complication

Intervention / Treatment
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* Device: UROSHIELD®
* Device: SHAM UROSHIELD®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive adult patients, with newly begun mechanical ventilation, will be connected to UROSHIELD® within 48 hours Exclusion Criteria: Pediatric patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UROSHIELD®<br>Randomly selected patients,(ratio 1:1) with newly begun mechanical ventilation, will be connected to a low energy acustic wave generator UROSHIELD® within 48 hours. Endotracheal secretions will be collected for culture and antibiotic sensitivity every 3 days for 15 consecutive days or until disconnection from the mechanical ventilation. | Device: UROSHIELD®<br>* An active UROSHIELD® device (low energy acustic wave generator) will be connected to an intratracheal tube externally. The device will transform low energy ultrasound waves on to the tube. These waves will by assumption lower the formation of bacterial growth and resistance to antibiotics.<br>* Other names: LUNGSHIELD®;|
| Sham Comparator: SHAM UROSHIELD®<br>same as abouve but with Sham device. | Device: SHAM UROSHIELD®<br>* SHAM UROSHIELD® will be connected to endotracheal tubes unable to transform any waves.<br>* Other names: SHAM LUNGSHIELD®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days elapse until development of positive sputum culture | Sputum for culture will be obtained every 3 days. Number of days till sputum culture will convert from negative to positive one will be calculated and compared for the study and control groups. | 15-20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of bacteria and antibiotic sensitivity | Types of bacteria and their sensitivities to antibiotics will be evaluated. Comparison will be done between rate of growth of serious pathogens (e.g., Methicillin resistant staphylococcus aureus (MRSA),Vancomycin-Resistant Enterococci (VRE)) in the study and control groups. Rate of resistance development to antibiotics will also be compared. | 15-20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endotracheal intubation, low energy ultrasound, sputum culture