COMPLETED

In Line Aerosol Nebulization With High Flow

Conditions

Hypoxemic Respiratory Failure Airway Obstruction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

In Line Aerosol Nebulization With High Flow

Quick Facts

Study Start:2023-09-01

Study Completion:2025-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05880836

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Igor Barjaktarevic, MD, PhD

PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Study Locations (Sites)

Ronald Reagan Medical Center at UCLA

Los Angeles, California, 90095

United States

Santa Monica UCLA

Santa Monica, California, 90404

United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Igor Barjaktarevic, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01

Study Completion Date2025-01-01

Study Record Updates

Study Start Date2023-09-01

Study Completion Date2025-01-01

Terms related to this study

Additional Relevant MeSH Terms

Hypoxemic Respiratory Failure
Airway Obstruction