Trial Outcomes & Findings for RCT of Mesh Versus Jet Nebulizers on Clinical Outcomes During Mechanical Ventilation in the Intensive Care Unit (NCT NCT02056119)
NCT ID: NCT02056119
Last Updated: 2023-03-21
Results Overview
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.")
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
duration of mechanical ventilation or discharge from the intensive care unit
Results posted on
2023-03-21
Participant Flow
The sample size was one of consecutive convenience (September 2013- August 2014). This study included adult subjects, greater than 18 years of age, receiving mechanical ventilation through an endotracheal tube (ETT) in the intensive care unit (ICU) with a physician order for aerosol treatment. Excluded were subjects receiving mechanical ventilation through a tracheostomy or diagnosed with diaphragmatic paralysis, paraplegia, high spinal cord injury, or brain death.
Participant milestones
| Measure |
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.
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
|
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.
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 staf
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
62
|
|
Overall Study
COMPLETED
|
48
|
42
|
|
Overall Study
NOT COMPLETED
|
10
|
20
|
Reasons for withdrawal
| Measure |
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.
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
|
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.
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 staf
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Intubated for less than 24 hrs
|
2
|
7
|
|
Overall Study
No aerosol treatments were given.
|
3
|
2
|
|
Overall Study
Received Metaneb treatment
|
0
|
2
|
|
Overall Study
Protocol Violation
|
4
|
7
|
Baseline Characteristics
RCT of Mesh Versus Jet Nebulizers on Clinical Outcomes During Mechanical Ventilation in the Intensive Care Unit
Baseline characteristics by cohort
| Measure |
Jet Nebulizer Arm
n=48 Participants
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.
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
|
Vibrating Mesh Nebulizer Arm
n=42 Participants
* 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.
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 staf
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
64.0 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
20 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Indian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
The Acute Physiology and Chronic Health Evaluation (APACHE II)
|
20.6 units on a scale
STANDARD_DEVIATION 7.6 • n=5 Participants
|
21.3 units on a scale
STANDARD_DEVIATION 8.6 • n=7 Participants
|
20.9 units on a scale
STANDARD_DEVIATION 8.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: duration of mechanical ventilation or discharge from the intensive care unitVentilator 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.")
Outcome measures
| Measure |
Jet Nebulizer Arm
n=48 Participants
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.
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.
|
Vibrating Mesh Nebulizer Arm
n=42 Participants
* 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.
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.
|
|---|---|---|
|
Venilator Associated Events (VAE)
Ventilator Associated Conditions · No
|
44 Participants
|
40 Participants
|
|
Venilator Associated Events (VAE)
Ventilator Associated Conditions · Yes
|
4 Participants
|
2 Participants
|
|
Venilator Associated Events (VAE)
Infection Related Ventilator Associated Conditions · No
|
46 Participants
|
42 Participants
|
|
Venilator Associated Events (VAE)
Infection Related Ventilator Associated Conditions · Yes
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: duration of mechanical ventilation or discharge from the intensive care unitPopulation: Cultures were not obtained for all participants.
While on mechanical ventilator, bacterial growth will be assessed from the vent circuit and nebulizer, and participant sputum.
Outcome measures
| Measure |
Jet Nebulizer Arm
n=47 Participants
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.
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.
|
Vibrating Mesh Nebulizer Arm
n=42 Participants
* 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.
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.
|
|---|---|---|
|
Participants With Bacterial Growth
Growth in Nebulizer · No
|
41 Participants
|
30 Participants
|
|
Participants With Bacterial Growth
Growth in Nebulizer · Yes
|
6 Participants
|
12 Participants
|
|
Participants With Bacterial Growth
Growth in Circuit · No
|
26 Participants
|
13 Participants
|
|
Participants With Bacterial Growth
Growth in Circuit · Yes
|
18 Participants
|
29 Participants
|
|
Participants With Bacterial Growth
Growth in Sputum Culture · No
|
7 Participants
|
3 Participants
|
|
Participants With Bacterial Growth
Growth in Sputum Culture · Yes
|
14 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: discharge from the intensive care unitTotal length of stay in intensive care unit in days
Outcome measures
| Measure |
Jet Nebulizer Arm
n=48 Participants
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.
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.
|
Vibrating Mesh Nebulizer Arm
n=42 Participants
* 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.
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.
|
|---|---|---|
|
Length of Stay in Intensive Care Unit
|
11.0 Days
Standard Deviation 8.3
|
14.1 Days
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: discharge from the intensive care unitTotal days spent on Mechanical Ventilator
Outcome measures
| Measure |
Jet Nebulizer Arm
n=48 Participants
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.
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.
|
Vibrating Mesh Nebulizer Arm
n=42 Participants
* 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.
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.
|
|---|---|---|
|
Days on Mechanical Ventilation
|
6.7 Days
Standard Deviation 7.1
|
9.7 Days
Standard Deviation 9.4
|
Adverse Events
Jet Nebulizer Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 14 deaths
Vibrating Mesh Nebulizer Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 15 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place