Nebulization treatment for patients with respiratory failure using high flow oxygen

In Line Aerosol Nebulization With High Flow

This study is testing a new way to deliver breathing medication using high flow oxygen for patients with respiratory failure to see if it works better and makes them feel more comfortable than the usual method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, Los Angeles (Academic / other)
• Locations: 2 sites (Los Angeles, California and 1 other locations)
• Trial ID: NCT05880836 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of a new method for delivering nebulized medication through a high flow nasal cannula in patients experiencing hypoxemic respiratory failure. It compares this approach, known as in-line nebulization with a vibrating mesh nebulizer, to traditional jet nebulization methods. The trial aims to assess patient comfort, resource utilization, and overall satisfaction with the different nebulization techniques. By using a double-crossover design, participants will receive both treatments to determine which is more beneficial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with mild to moderate hypoxemic respiratory failure who are receiving nebulized bronchodilator therapy.

Not a fit: Patients with severe hypoxemia or those requiring tracheostomy for oxygen delivery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer and more effective method for delivering bronchodilator therapy to patients with respiratory failure.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving nebulization delivery methods in respiratory care.

Eligibility criteria

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.

Where this trial is running

Los Angeles, California and 1 other locations

• Ronald Reagan Medical Center at UCLA — Los Angeles, California, United States (Recruiting)
• Santa Monica UCLA — Santa Monica, California, United States (Recruiting)

Study contacts

• Principal investigator: Igor Barjaktarevic, MD, PhD — University of California, Los Angeles
• Study coordinator: Matthew Dartt, BS

Conditions Hypoxemic Respiratory Failure; Airway Obstruction