RCT of Mesh Versus Jet Nebulizers on Clinical Outcomes During Mechanical Ventilation in the Intensive Care Unit
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ClinicalTrials.gov Identifier: NCT02056119 |
Recruitment Status :
Completed
First Posted : February 5, 2014
Last Update Posted : December 30, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Respiratory Insufficiency | Device: Vibrating Mesh Nebulizer Arm Device: Jet Nebulizer Arm | Not Applicable |

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:
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Device: Jet Nebulizer Arm
Other Name: Misty Max 10 nebulizer (Carefusion, California) |
Experimental: Vibrating Mesh Nebulizer Arm
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Device: Vibrating Mesh Nebulizer Arm
Other Name: Aeroneb Solo (Aerogen, Galway, Ireland) |
- 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.
- 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.
- Length of Stay in Intensive Care Unit [ Time Frame: for up to one year ]Total length of stay in intensive care unit in days
- Days on Mechanical Ventilation [ Time Frame: for up to one year ]Total days spent on Mechanical Ventilator
- Ventilator-Associated Tracheobronchitis [ Time Frame: for up to one year ]Was patient diagnosed with VATs while on mechanical ventilator

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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 |
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

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
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 |
Principal Investigator: | Meagan N Dubosky, MS | Rush University, Respiratory Care Research Coordinator |
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 |
Ventilators, mechanical Aerosol Drug Therapy Nebulizers Equipment Contamination vibrating mesh nebulizer |
jet nebulizer mechanical ventilation ventilator associated event ventilator associated tracheobronchitis |
Respiratory Insufficiency Pulmonary Valve Insufficiency Respiration Disorders Respiratory Tract Diseases |
Heart Valve Diseases Heart Diseases Cardiovascular Diseases |