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N/A N=120 Randomized Basic Science

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

Respiratory Insufficiency

Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Venilator Associated Events (VAE) — 44; 40; 4; 2 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Vibrating Mesh Nebulizer Arm (Device); Jet Nebulizer Arm (Device)
Age
Pediatric, Adult, Older Adult · 1+ yrs
Sex
All
Sponsor
Rush University Medical Center
Primary completion
Oct 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Venilator Associated Events (VAE)
44; 40; 4; 2; 46; 42
SECONDARY
Participants With Bacterial Growth
41; 30; 6; 12; 26; 13
SECONDARY
Length of Stay in Intensive Care Unit
11.0; 14.1
SECONDARY
Days on Mechanical Ventilation
6.7; 9.7

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02056119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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