CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Vibrating Mesh Nebulizer Arm +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02056119
NCT02056119N/ACompleted

Randomized Controlled Trial of Mesh Versus Jet Nebulizers on Clinical Outcomes During Mechanical Ventilation in the Intensive Care Unit

Rush University Medical Center·interventional·Posted Feb 5, 2014·Updated Mar 21, 2023

In Brief

A clinical study evaluating Vibrating Mesh Nebulizer Arm and Jet Nebulizer Arm for Respiratory Insufficiency. Completed, enrolled 120 participants across 1 site.

Detailed Summary

Aerosol delivery during mechanical ventilation has long been a long debated topic. As evidence-based knowledge about the delivery of aerosol to the lungs of mechanically ventilated patients increases, one piece of the puzzle has remained unexplored; measurement of clinically relevant outcomes. The primary aim of this research is to compare clinical outcomes (ventilator-associated events (VAEs), length of stay (LOS) in intensive care unit (ICU), and total days on mechanical ventilation) when using a traditional jet nebulizer versus a newer generation vibrating mesh nebulizer during mechanical ventilation. The secondary aim of this research is to identify source of bacteria by obtaining cultures of each nebulizer and ventilator circuit and plating them for colony growth and identification.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 5, 2014
Enrollment StartSep 1, 2013
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.4 years ago

Interventions

Vibrating Mesh Nebulizer Armdevice

* Physician order received for subject, randomization to vibrating mesh nebulizer occurred. * Aeroneb® Solo (Aerogen, Galway, Ireland) vibrating mesh nebulizer to be placed before the heater on the "dry side" of the heater water chamber on the inspiratory ventilator circuit. * Aerosol treatment delivered per physician order. * Mesh nebulizer to be replaced every 30 days per hospital protocol. a. Prior to every nebulizer change or every 3 days, study staff to be notified in order to obtain cultures.

Jet Nebulizer Armdevice

* Physician order received for subject, randomization to jet nebulizer occurred. * Jet nebulizer, Misty Max 10™ (Carefusion, CA), placed into spring loaded t-piece between the humidifier and the ventilator (approximately 15 cm from the gas outlet). * Aerosol treatment delivered per physician order at flow rates of 8-10 L/min. * Jet nebulizer to be replaced every 3 days per hospital protocol. a. Prior to every nebulizer change or every 3 days, study staff to be notified in order to obtain cultures.