Does UROSHIELD® Influence Bacterial Growth On Endotracheal Tubes
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Shaare Zedek Medical Center
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- Number of days elapse until development of positive sputum culture
Study Overview
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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Consecutive adult patients, with newly begun mechanical ventilation, will be connected to UROSHIELD® within 48 hours
Exclusion Criteria
- •Pediatric patients
Arms & Interventions
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.
Intervention: UROSHIELD® (Device)
SHAM UROSHIELD®
same as abouve but with Sham device.
Intervention: SHAM UROSHIELD® (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Type of bacteria and antibiotic sensitivity(15-20 days)
Investigators
REUVEN FRIEDMANN
head of geriatric ward
Shaare Zedek Medical Center