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Procedure

High-Flow Nebulization for Respiratory Insufficiency (ILAN Trial)

N/A

Recruiting

Led By Igor Barjaktarevic, MD, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 hours

Awards & highlights

ILAN Trial Summary

This trial tests a safer, more convenient way to give bronchodilators to hypoxemic respiratory failure patients, and compares it to the current method.

Who is the study for?

This trial is for adults over 18 with mild or moderate hypoxemic respiratory failure, already receiving high-flow nasal cannula (HFNC) oxygen and nebulized bronchodilator therapy. Respiratory therapists participating must work at SMICU or RRMC. Patients excluded are those not meeting these specific conditions.Check my eligibility

What is being tested?

The study compares two ways to give bronchodilators: one using a new method of in-line aerosol nebulization while maintaining HFNC oxygen, and the other using standard jet nebulization with a face mask. The goal is to see which is safer and more effective for patients with breathing difficulties.See study design

What are the potential side effects?

Potential side effects may include discomfort from the delivery methods, possible irritation from the masks or nasal cannulas, and typical reactions to bronchodilators like jitteriness, heart palpitations, dry mouth, or headaches.

ILAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have received at least one dose of nebulizer therapy as prescribed.

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I use a nebulizer with specific medications up to every 3 hours but no less than every 6 hours.

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I have mild or moderate difficulty breathing and am being treated with a high-flow nasal cannula.

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I work as a Respiratory Therapist at SMICU or RRMC.

ILAN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change in respiratory rate during nebulization compared to the baseline rate

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

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

+6 more

Other outcome measures

Compliance with the study protocol

Duration of nebulizer delivery

Modified BORG score

+3 more

ILAN Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Path A (vibrating mesh nebulizer (VMN) with the high flow nasal cannula)Experimental Treatment2 Interventions

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 II: Path B (standard jet nebulization (SJN) with face mask)Active Control2 Interventions

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,532 Previous Clinical Trials

10,265,228 Total Patients Enrolled

AerogenIndustry Sponsor

5 Previous Clinical Trials

338 Total Patients Enrolled

Igor Barjaktarevic, MD, PhDPrincipal InvestigatorUniversity of California, Los Angeles

1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an open enrollment period for this research project?

"Affirmative. Clinicaltrials.gov has shown that this clinical trial, with its original post date of September 1st 2023, is currently seeking 40 participants from two medical centres. The latest updates were to the study on December 1st 2023."

Answered by AI

What is the capacity for participants in this experiment?

"Affirmative. Per information hosted on clinicaltrials.gov, this experiment is currently in the process of enrolling participants with an initial posting date of September 1st 2023 and a most recent update dated December 1st 2023. In total, 40 patients are needed between two different medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

In Line Aerosol Nebulization With High Flow

Igor Barjaktarevic, MD, PhD 2023. "In Line Aerosol Nebulization With High Flow". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05880836.