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In Line Aerosol Nebulization With High Flow (ILAN)

Primary Purpose

Hypoxemic Respiratory Failure, Airway Obstruction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nebulizer via in-line drug delivery maintaining high-flow nasal cannula oxygen
standard jet nebulization (SJN) with face mask
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypoxemic Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    Arm Type

    Experimental

    Active Comparator

    Arm Label

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

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

    Arm Description

    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.

    Outcomes

    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
    Primary Outcome

    Secondary Outcome Measures

    Proportion of patients with documented hypoxemia (<88%) during the nebulization
    Safety Outcome
    Duration of hypoxemic episodes with SpO2<88% during the nebulization delivery
    Safety Outcome
    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
    Increase in respiratory rate from the baseline during the nebulization by >10%
    Safety Outcome
    Change in respiratory rate during nebulization compared to the baseline rate
    Safety Outcome
    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) )
    Need to increase O2 support after the nebulization therapy to maintain SpO2>88%
    Safety Outcome
    Nosebleed within 2 hours of nebulizer delivery
    Safety Outcome
    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)

    Full Information

    First Posted
    March 8, 2023
    Last Updated
    May 25, 2023
    Sponsor
    University of California, Los Angeles
    Collaborators
    Aerogen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05880836
    Brief Title
    In Line Aerosol Nebulization With High Flow
    Acronym
    ILAN
    Official Title
    In Line Aerosol Nebulization With High Flow
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    July 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Los Angeles
    Collaborators
    Aerogen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypoxemic Respiratory Failure, Airway Obstruction

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    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)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Path A (vibrating mesh nebulizer (VMN) with the high flow nasal cannula)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Path B (standard jet nebulization (SJN) with face mask)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    nebulizer via in-line drug delivery maintaining high-flow nasal cannula oxygen
    Intervention Description
    nebulized delivery of bronchodilator via in-line drug delivery maintaining high-flow nasal cannula oxygen
    Intervention Type
    Device
    Intervention Name(s)
    standard jet nebulization (SJN) with face mask
    Intervention Description
    standard jet nebulization delivery of bronchodilator
    Primary Outcome Measure Information:
    Title
    Maximal decrease in SpO2 during nebulization with jet nebulizer vs. inline via HFNC compared to the baseline SpO2 values prior to the nebulization therapy
    Description
    Primary Outcome
    Time Frame
    up to 48 hours
    Secondary Outcome Measure Information:
    Title
    Proportion of patients with documented hypoxemia (<88%) during the nebulization
    Description
    Safety Outcome
    Time Frame
    up to 48 hours
    Title
    Duration of hypoxemic episodes with SpO2<88% during the nebulization delivery
    Description
    Safety Outcome
    Time Frame
    up to 48 hours
    Title
    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
    Description
    Safety Outcome
    Time Frame
    up to 48 hours
    Title
    Increase in respiratory rate from the baseline during the nebulization by >10%
    Description
    Safety Outcome
    Time Frame
    up to 48 hours
    Title
    Change in respiratory rate during nebulization compared to the baseline rate
    Description
    Safety Outcome
    Time Frame
    up to 48 hours
    Title
    Requirement for additional interventions to maintain patient's safety during the nebulization
    Description
    Safety Outcome: (Increased O2 flow (yes/know and rate increase) or increased O2 FiO2 (yes/know and rate increase) )
    Time Frame
    up to 48 hours
    Title
    Need to increase O2 support after the nebulization therapy to maintain SpO2>88%
    Description
    Safety Outcome
    Time Frame
    up to 48 hours
    Title
    Nosebleed within 2 hours of nebulizer delivery
    Description
    Safety Outcome
    Time Frame
    up to 48 hours
    Title
    ROX score
    Description
    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)
    Time Frame
    up to 48 hours
    Other Pre-specified Outcome Measures:
    Title
    Portion of patients able to complete the nebulization therapy
    Description
    Feasibility Outcome
    Time Frame
    up to 48 hours
    Title
    Patient satisfactory survey score
    Description
    Feasibility Outcome: (5 question, 7-point scale ranging from very uncomfortable to very comfortable)
    Time Frame
    up to 48 hours
    Title
    Modified BORG score
    Description
    Safety Outcome (Introduced by Gunnar Borg, rates exertion on a scale of 6-20, from lowest to highest)
    Time Frame
    up to 48 hours
    Title
    Compliance with the study protocol
    Description
    Feasibility Outcome (number of study drug doses which are missed during the study period)
    Time Frame
    up to 48 hours
    Title
    Duration of nebulizer delivery
    Description
    Feasibility Outcome
    Time Frame
    up to 48 hours
    Title
    Respiratory therapist time utilization as reflected in the total time spent delivering the nebulization in 2-minute increments
    Description
    Feasibility Outcome
    Time Frame
    up to 48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Matthew Dartt, BS
    Phone
    4142598904
    Email
    mdartt@mednet.ucla.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    D'Mitri Champion, BS
    Phone
    3102678927
    Email
    dchampion@mednet.ucla.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Igor Barjaktarevic, MD, PhD
    Organizational Affiliation
    University of California, Los Angeles
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    as below
    IPD Sharing Time Frame
    after the study completion, for 3 years
    IPD Sharing Access Criteria
    direct contact with the study team
    Citations:
    Citation
    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
    Results Reference
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