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

Shaare Zedek Medical Center

Status: Unknown

Conditions: Mechanical Ventilation Complication

Treatments: Device: SHAM UROSHIELD®; Device: UROSHIELD®

Study type: Interventional

Funder types: Other

Identifiers

NCT02074306

SZMCenter IRB (Other Identifier)

109/13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pediatric patients

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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66 participants in 2 patient groups

UROSHIELD®

Experimental group

Description:

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.

Treatment:

Device: UROSHIELD®

SHAM UROSHIELD®

Sham Comparator group

Description:

same as abouve but with Sham device.

Treatment:

Device: SHAM UROSHIELD®