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Trial record 28 of 415 for:    shaare zedek

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

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ClinicalTrials.gov Identifier: NCT02074306
Recruitment Status : Recruiting
First Posted : February 28, 2014
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
REUVEN FRIEDMANN, Shaare Zedek Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Complication Device: UROSHIELD® Device: SHAM UROSHIELD® Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Does UROSHIELD® Influence Bacterial Growth On Endotracheal Tubes
Study Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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 Name: 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 Name: SHAM LUNGSHIELD®




Primary Outcome Measures :
  1. Number of days elapse until development of positive sputum culture [ Time Frame: 15-20 days ]
    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.


Secondary Outcome Measures :
  1. Type of bacteria and antibiotic sensitivity [ Time Frame: 15-20 days ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pediatric patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02074306


Contacts
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Contact: Reuven Friedmann, Dr +972508685156 reufri@szmc.org.il

Locations
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Israel
Medical wing, Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 9103102
Contact: Reuven Friedmann, Dr    972508685156    reufri@szmc.org.il   
Principal Investigator: Reuven Friedmann, Dr         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Study Director: Reuven Friedmann, Dr Shaare Zedek Medical Center

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Responsible Party: REUVEN FRIEDMANN, head of geriatric ward, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02074306     History of Changes
Other Study ID Numbers: 109/13
SZMCenter IRB ( Other Identifier: Shaare Zedek Medical Center IRB )
First Posted: February 28, 2014    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

Keywords provided by REUVEN FRIEDMANN, Shaare Zedek Medical Center:
endotracheal intubation
low energy ultrasound
sputum culture