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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02056119
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Device: Vibrating Mesh Nebulizer Arm Device: Jet Nebulizer Arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Randomized Controlled Trial of Mesh Versus Jet Nebulizers on Clinical Outcomes During Mechanical Ventilation in the Intensive Care Unit
Study Start Date : December 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Active Comparator: Jet Nebulizer Arm

The 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.
Device: Jet Nebulizer Arm
  • 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.
Other Name: Misty Max 10 nebulizer (Carefusion, California)

Experimental: Vibrating Mesh Nebulizer Arm
  • 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.
Device: Vibrating Mesh Nebulizer Arm
  • 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.
Other Name: Aeroneb Solo (Aerogen, Galway, Ireland)




Primary Outcome Measures :
  1. Venilator Associated Events [ Time Frame: for up to one year ]

    according to 2013 NHSN Surveillance for VAEs

    For use in patients > or equal to 18 years of age who are on mechanical ventilation for greater or equal to 3 calendar days.



Secondary Outcome Measures :
  1. Bacterial Count and type [ Time Frame: for up to one year ]
    while on mechanical ventilator, bacterial count and type will be assessed from the vent circuit and nebulizer.

  2. Length of Stay in Intensive Care Unit [ Time Frame: for up to one year ]
    Total length of stay in intensive care unit in days

  3. Days on Mechanical Ventilation [ Time Frame: for up to one year ]
    Total days spent on Mechanical Ventilator

  4. Ventilator-Associated Tracheobronchitis [ Time Frame: for up to one year ]
    Was patient diagnosed with VATs while on mechanical ventilator



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056119


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Meagan N Dubosky, MS Rush University, Respiratory Care Research Coordinator
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02056119    
Other Study ID Numbers: 13070203
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Keywords provided by Rush University Medical Center:
Ventilators, mechanical
Aerosol Drug Therapy
Nebulizers
Equipment Contamination
vibrating mesh nebulizer
jet nebulizer
mechanical ventilation
ventilator associated event
ventilator associated tracheobronchitis
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases