Does UROSHIELD® Influence Bacterial Growth On Endotracheal Tubes (lungshield)

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.

Study Overview

• Status: Unknown
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Device: UROSHIELD®; Device: SHAM UROSHIELD®

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reuven Friedmann, Dr; Phone Number: +972508685156; Email: reufri@szmc.org.il

Study Locations

• Israel
  • Jerusalem, Israel, 9103102
    • Recruiting
    • Medical wing, Shaare Zedek Medical Center
    • Contact: Reuven Friedmann, Dr; Phone Number: 972508685156; Email: reufri@szmc.org.il
    • Principal Investigator: Reuven Friedmann, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Consecutive adult patients, with newly begun mechanical ventilation, will be connected to UROSHIELD® within 48 hours

Exclusion Criteria:

• Pediatric patients

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UROSHIELD®; 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®; 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.; Other Names: LUNGSHIELD®
Sham Comparator: SHAM UROSHIELD®; same as abouve but with Sham device.	Device: SHAM UROSHIELD®; SHAM UROSHIELD® will be connected to endotracheal tubes unable to transform any waves.; Other Names: SHAM LUNGSHIELD®

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (Estimate): February 28, 2014

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 5, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: endotracheal intubation; low energy ultrasound; sputum culture
• Other Study ID Numbers: 109/13; SZMCenter IRB (Other Identifier: Shaare Zedek Medical Center IRB)