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In Line Aerosol Nebulization With High Flow

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Brief Summary

The objective of ILAN is to assess the safety, feasibility and bronchodilator efficacy of in-line bronchodilator nebulizer delivery with VMN via HFNC system in hypoxemic respiratory failure patients treated with bronchodilators and compare this method to standard-nebulization using a jet nebulizer with a facial mask. The investigators hypothesized that aerosol nebulization using HFNC/VMN represents safer and more convenient approach in hypoxemic respiratory failure patients in comparison to conventional therapy while providing similar bronchodilator efficacy.

Primary Purpose
Supportive Care
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Adults ≥ 18 years of age
  • Patients with mild or moderate hypoxemic respiratory failure (with or without acute hypercapnic respiratory failure) treated with HFNC.
  • Nebulizer therapy ordered by the primary team with at least one dose delivered prior to the enrollment into the study
  • Patients must be on ordered nebulized albuterol, levalbuterol, ipratropium or ipratropium/albuterol combination with a maximum of Q3 or a minimum of Q6 hour frequencies.
  • For Respiratory Therapists: They must be employees of SMICU or RRMC.

Exclusion Criteria:

  • Lack of hypoxemia defined as SpO2> 92% on room air
  • Severe hypoxemia defined by PaO2/FiO2<100 or SpO2<92% on HFNC settings: ≥ FiO2 80% or higher and O2 flow 40L/min
  • HFNC O2 delivery via tracheostomy
  • COVID-19 positive status (within 3 weeks prior to the enrollment)
  • Respiratory distress, defined by respiratory rate > 24 breath per minute
  • Hemodynamic instability defined by the use of two or more vasopressor medications
  • Presence of nasal obstruction that may pose a risk for inadequate nebulizer delivery in the opinion of the investigator
  • Pulmonary comorbidities that, in the opinion of the investigator or clinical team, can pose a risk to subject safety or interfere with the subject's ability to complete the study procedures.
  • Moribund patient not expected to survive >24 hours
  • Inability to obtain informed consent from patient
  • Respiratory therapists who are unwilling to participate.

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Study Stats
Protocol No.
21-001966
Category
Lung/Respiratory Disorders
Contact
MATTHEW DARTT
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05880836
For detailed technical eligibility, visit ClinicalTrials.gov.