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Respiratory Insufficiency | RCT of Mesh Versus Jet Nebulizers on Clinical Outcomes During Mechanical Ventilation in the Intensive Care Unit

Respiratory Insufficiency research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Age > 1 y/o - Intubated with endotracheal tube (ETT) and on mechanical ventilation - Patient in all intensive care units at Rush University Medical Center - Physician order for aerosolized breathing treatment in medical record Exclusion Criteria: - Age < 1 y/o - Diaphragmatic paralysis - Paraplegic or high spinal cord injury - Brain death

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Respiratory Insufficiency

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Vibrating Mesh Nebulizer ArmPhysician 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.

Device:Jet Nebulizer ArmPhysician 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Jet Nebulizer ArmThe Jet Nebulizer Protocol: 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.

Vibrating Mesh Nebulizer ArmPhysician 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.

Study Status

Completed

Start Date: December 2013

Completed Date: October 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Venilator Associated Events

Secondary Outcome: Bacterial Count and type

Study sponsors, principal investigator, and references

Principal Investigator: Meagan N Dubosky, MS

Lead Sponsor: Rush University Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02056119

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