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

NCT02056119 | Completed Results

• 1 other identifier: 13070203
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency

Keywords

Ventilators, mechanical; Aerosol Drug Therapy; Nebulizers; Equipment Contamination; vibrating mesh nebulizer; jet nebulizer; mechanical ventilation; ventilator associated event; ventilator associated tracheobronchitis

Outcome Measures

Primary Outcomes (1)

• Venilator Associated Events (VAE)

  Ventilator associated conditions (VAC) and infection related ventilator associated conditions (IVAC) were identified based on the 2013 NHSN Surveillance for VAEs (e,g., "See page 92 at https://www.cdc.gov/nhsn/PDFs/pscManual/validation/2013-PSC-Manual-validate.pdf for detailed criteria.")

  duration of mechanical ventilation or discharge from the intensive care unit

Secondary Outcomes (3)

• Participants With Bacterial Growth

  duration of mechanical ventilation or discharge from the intensive care unit

• Length of Stay in Intensive Care Unit

  discharge from the intensive care unit

• Days on Mechanical Ventilation

  discharge from the intensive care unit

Study Arms (2)

Jet Nebulizer Arm

ACTIVE COMPARATOR

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

Vibrating Mesh Nebulizer Arm

EXPERIMENTAL

* 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

Interventions

Vibrating Mesh Nebulizer Arm DEVICE

* 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.

Also known as: Aeroneb Solo (Aerogen, Galway, Ireland)

Vibrating Mesh Nebulizer Arm

Jet Nebulizer Arm DEVICE

* 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.

Also known as: Misty Max 10 nebulizer (Carefusion, California)

Jet Nebulizer Arm

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 1 y/o
• Diaphragmatic paralysis
• Paraplegic or high spinal cord injury
• Brain death

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Results Point of Contact

• Title: David Vines, PhD, RRT
• Organization: Rush University Medical Center

david_vines@rush.edu

3129424408

Study Officials

• Meagan N Dubosky, MS

  Rush University, Respiratory Care Research Coordinator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: February 5, 2014
• Study Start: September 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 21, 2023
• Results First Posted: March 21, 2023

Record last verified: 2023-03

Locations

US (1)