In Line Aerosol Nebulization With High Flow

NCT ID: NCT05880836

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-01-01

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.

Detailed Description

Objective: To evaluate the safety and feasibility of a novel approach to nebulization treatment via the nasal route in patients with severe hypoxemic respiratory failure dependent on high flow oxygen.

Hypothesis: In-line vibrating mesh nebulizer delivery via HFNC systems is a safe, feasible and efficacious approach in comparison to traditional jet nebulizer delivered nebulization in hypoxemic respiratory failure patients whose usual care includes nebulized drugs.

Specific Aims:

1. To evaluate the safety and feasibility of administering vibrating mesh nebulizer-delivered therapy in patients with acute hypoxemic respiratory failure requiring high flow nasal cannula.

2. To evaluate the effect of trans-nasal nebulization on patient comfort and satisfaction with therapy in comparison with standard jet nebulization.

3. To evaluate differences in resource utilization between patients receiving standard jet nebulization and ILAN with HF, including time spent at the bedside by the respiratory therapist (RT) for delivery of the medication and any additional time gathering setting up and cleaning.

4. To evaluate patient and therapist perceptions and preference on the various delivery methods of aerosol delivery.

Study Design: ILAN is a double-crossover, multi-center trial evaluating the safety and feasibility of in line nebulized medication with high flow nasal canula in comparison to standard jet nebulizer therapy in acute respiratory failure requiring the utilization of high flow nasal cannula.

Intervention: 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 selected 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.

Conditions

Hypoxemic Respiratory Failure; Airway Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Path A (vibrating mesh nebulizer (VMN) with the high flow nasal cannula)

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.

Group Type: EXPERIMENTAL

nebulizer via in-line drug delivery maintaining high-flow nasal cannula oxygen

Intervention Type: DEVICE

nebulized delivery of bronchodilator via in-line drug delivery maintaining high-flow nasal cannula oxygen

standard jet nebulization (SJN) with face mask

Intervention Type: DEVICE

standard jet nebulization delivery of bronchodilator

Path B (standard jet nebulization (SJN) with face mask)

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.

Group Type: ACTIVE_COMPARATOR

nebulizer via in-line drug delivery maintaining high-flow nasal cannula oxygen

Intervention Type: DEVICE

nebulized delivery of bronchodilator via in-line drug delivery maintaining high-flow nasal cannula oxygen

standard jet nebulization (SJN) with face mask

Intervention Type: DEVICE

standard jet nebulization delivery of bronchodilator

Interventions

nebulizer via in-line drug delivery maintaining high-flow nasal cannula oxygen

nebulized delivery of bronchodilator via in-line drug delivery maintaining high-flow nasal cannula oxygen

Intervention Type: DEVICE

standard jet nebulization (SJN) with face mask

standard jet nebulization delivery of bronchodilator

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aerogen

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Igor Barjaktarevic, MD, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Igor Barjaktarevic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Ronald Reagan Medical Center at UCLA

Los Angeles, California, United States

Santa Monica UCLA

Santa Monica, California, United States

Countries

United States

References

1. Rochwerg, B. Intensive Care Med, 2020 2. Li, J. Respir Care, 2021 3. Reminiac, F. Ann Intensive Care, 2018 4. Li, J. Crit Care, 2020. 5. Dugernier, J., J Aerosol Med Pulm Drug Deliv, 2019 6. Leung, C.C.H. J Hosp Infect, 2019 7. Reminiac, F., J Aerosol Med Pulm Drug Deliv, 2016 8. Berlinski, A. Respir Care, 2013 9. Ari, A., J Aerosol Med Pulm Drug Deliv, 2015 10. Ari, A., Respir Care, 2010 11. Alcoforado, L., Pharmaceutics, 2019 12. Bennett, G., Intensive Care Med Exp, 2019 13. Dugernier, J.,J Aerosol Med Pulm Drug Deliv, 2017 14. Zielinski, J., Chest, 1995 15. Ringbaek, T. and K. Viskum, Respir Med, 2003 16. Rezaie, N. J Res Med Sci, 2013 17. Rennard, S.I., Chest, 1996 18. Ogale, S.S., Chest, 2010 19. Drake, M.G., Ann Am Thorac Soc, 2018 20. Valencia-Ramos, J., Respir Care, 2018

Reference Type: BACKGROUND

Other Identifiers

21-001966

Identifier Type: -

Identifier Source: org_study_id