In Line Aerosol Nebulization With High Flow

NCT05880836 | Completed

• 1 other identifier: 21-001966
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypoxemic Respiratory Failure; Airway Obstruction

Outcome Measures

Primary Outcomes (1)

• Maximal decrease in SpO2 during nebulization with jet nebulizer vs. inline via HFNC compared to the baseline SpO2 values prior to the nebulization therapy

  Primary Outcome

  up to 48 hours

Secondary Outcomes (9)

• Proportion of patients with documented hypoxemia (<88%) during the nebulization

  up to 48 hours

• Duration of hypoxemic episodes with SpO2<88% during the nebulization delivery

  up to 48 hours

• Lowest absolute desaturation from the beginning until completion of nebulizer treatment compared to the baseline SpO2 values defined as the lowest adequately measured SpO2 within two minutes prior to the nebulization

  up to 48 hours

• Increase in respiratory rate from the baseline during the nebulization by >10%

  up to 48 hours

• Change in respiratory rate during nebulization compared to the baseline rate

  up to 48 hours

Other Outcomes (6)

• Portion of patients able to complete the nebulization therapy

  up to 48 hours

• Patient satisfactory survey score

  up to 48 hours

• Modified BORG score

  up to 48 hours

Study Arms (2)

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

EXPERIMENTAL

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.

Device: nebulizer via in-line drug delivery maintaining high-flow nasal cannula oxygen; Device: standard jet nebulization (SJN) with face mask

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

ACTIVE COMPARATOR

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.

Device: nebulizer via in-line drug delivery maintaining high-flow nasal cannula oxygen; Device: standard jet nebulization (SJN) with face mask

Interventions

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

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

Path A (vibrating mesh nebulizer (VMN) with the high flow nasal cannula); Path B (standard jet nebulization (SJN) with face mask)

standard jet nebulization (SJN) with face mask DEVICE

standard jet nebulization delivery of bronchodilator

Path A (vibrating mesh nebulizer (VMN) with the high flow nasal cannula); Path B (standard jet nebulization (SJN) with face mask)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Aerogen: collaborator

Study Sites (2)

Ronald Reagan Medical Center at UCLA

Los Angeles, California, 90095, United States

Location

Santa Monica UCLA

Santa Monica, California, 90404, United States

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Airway Obstruction

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Igor Barjaktarevic, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: HFNC with trans-nasal aerosol delivery is a multi-center trial comparing nebulization of medications via trans-nasal delivery with vibrating mesh nebulizer to standard jet nebulization in patients with mild or moderate hypoxemic respiratory failure (with or without acute hypercapnic respiratory failure) treated with HFNC. The crossover nature of the study is reflected in the universal application of bronchodilators via both study interventions (HFNC/VMN and FM/SJN) in all subjects but in variable order depending on the randomization of subjects into Path A or Path B

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: May 30, 2023
• Study Start: September 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after the study completion, for 3 years
• Access Criteria: direct contact with the study team

Locations

US (2)