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In Line Aerosol Nebulization With High Flow
About
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
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
Principal Investigator
Contact
Location
- UCLA Westwood