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Hypoxemic Respiratory FailureILANNCT05880836

In Line Aerosol Nebulization With High Flow

A study testing nebulizer via in-line drug delivery maintaining high-flow nasal cannula oxygen and standard jet nebulization (SJN) with face mask in people with Hypoxemic Respiratory Failure and Airway Obstruction, run by University of California, Los Angeles at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
nebulizer via in-line drug delivery maintaining high-flow nasal cannula oxygen and standard jet nebulization (SJN) with face mask
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
1 Sep 2023to 1 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Ronald Reagan Medical Center at UCLA

    Los Angeles, California, 90095

  • Santa Monica UCLA

    Santa Monica, California, 90404

Other trials in United States

About this study

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.

Read the 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.

Being tested
nebulizer via in-line drug delivery maintaining high-flow nasal cannula oxygen, standard jet nebulization (SJN) with face mask
Medical subject headings
Respiratory Insufficiency, Airway Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

  • standard jet nebulization (SJN) with face maskDevice

    standard jet nebulization delivery of bronchodilator

Study groups in NCT05880836
Study groupRoleWhat they receive
Path A (vibrating mesh nebulizer (VMN) with the high flow nasal cannula)ExperimentalEnrolled 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.
Receives: 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 comparatorPath 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.
Receives: Device: nebulizer via in-line drug delivery maintaining high-flow nasal cannula oxygen; Device: standard jet nebulization (SJN) with face mask

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 48 hours

Secondary outcomes (9)
  1. Proportion of patients with documented hypoxemia (<88%) during the nebulization

    Safety Outcome

    Measured: up to 48 hours

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

    Safety Outcome

    Measured: up to 48 hours

  3. 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

    Safety Outcome

    Measured: up to 48 hours

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

    Safety Outcome

    Measured: up to 48 hours

  5. Change in respiratory rate during nebulization compared to the baseline rate

    Safety Outcome

    Measured: up to 48 hours

  6. Requirement for additional interventions to maintain patient's safety during the nebulization

    Safety Outcome: (Increased O2 flow (yes/know and rate increase) or increased O2 FiO2 (yes/know and rate increase) )

    Measured: up to 48 hours

  7. Need to increase O2 support after the nebulization therapy to maintain SpO2>88%

    Safety Outcome

    Measured: up to 48 hours

  8. Nosebleed within 2 hours of nebulizer delivery

    Safety Outcome

    Measured: up to 48 hours

  9. ROX score

    Safety Outcome (While not externally validated, the ROX Index is a simple bedside calculation using three clinical variables and is one easy way to summarize a patient's degree of hypoxemic respiratory failure - gives risk of intubation - low to high)

    Measured: up to 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2023
  2. Study start1 Sep 2023
  3. Primary completion1 Jan 2025
  4. Study completion1 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
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
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05880836
Sponsor's protocol ID
21-001966
Acronym
ILAN
Status last verified
Mar 2025
First submitted
8 Mar 2023
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: as below

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing nebulizer via in-line drug delivery maintaining high-flow nasal cannula oxygen and standard jet nebulization (SJN) with face mask in people with Hypoxemic Respiratory Failure and Airway Obstruction, run by University of California, Los Angeles at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal decrease in SpO2 during nebulization with jet nebulizer vs. inline via HFNC compared to the baseline SpO2 values prior to the nebulization therapy (time frame: up to 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05880836, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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