In Line Aerosol Nebulization With High Flow (ILAN)
Hypoxemic Respiratory Failure, Airway Obstruction
About this trial
This is an interventional supportive care trial for Hypoxemic Respiratory Failure
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Path A (vibrating mesh nebulizer (VMN) with the high flow nasal cannula)
Path B (standard jet nebulization (SJN) with face mask)
Enrolled patients will receive two standard forms of inhaled medications as ordered by the physician. Patients will be randomized into two paths of the cross over study. There will be no blinding involved in this randomization. Path A will have medications delivered trans-nasally in line via the vibrating mesh nebulizer (VMN) with the high flow nasal cannula followed by standard jet nebulization (SJN) with face mask at the next time of medication dosing 3-6 hours later.
Path B will receive standard jet nebulization without HFNC followed by the trans-nasal in line nebulization via the HFNC. Patients agreed to enroll in day 2 of the trial will have their clinical path alternated in attempt to control for diurnal variability. All patients will also receive as-needed nebulized treatments as well as usual supportive care provided by respiratory therapists. As needed therapy will be delivered via the method of the current arm of the study they are in, and the washout period will subsequently reset.