Does UROSHIELD® Influence Bacterial Growth On Endotracheal Tubes
lungshield
2 other identifiers
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2014
CompletedFirst Posted
Study publicly available on registry
February 28, 2014
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedAugust 7, 2018
August 1, 2018
2.7 years
February 13, 2014
August 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Type of bacteria and antibiotic sensitivity
15-20 days
Study Arms (2)
UROSHIELD®
EXPERIMENTALRandomly 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.
SHAM UROSHIELD®
SHAM COMPARATORsame as abouve but with Sham device.
Interventions
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.
SHAM UROSHIELD® will be connected to endotracheal tubes unable to transform any waves.
Eligibility Criteria
You may qualify if:
- Consecutive adult patients, with newly begun mechanical ventilation, will be connected to UROSHIELD® within 48 hours
You may not qualify if:
- Pediatric patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical wing, Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Study Officials
- STUDY DIRECTOR
Reuven Friedmann, Dr
Shaare Zedek Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- head of geriatric ward
Study Record Dates
First Submitted
February 13, 2014
First Posted
February 28, 2014
Study Start
April 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
August 7, 2018
Record last verified: 2018-08