The Role of Gas Flow in Transnasal Pulmonary Aerosol Delivery: A Double-blinded, Randomized Controlled Trial

March 9, 2020 updated by: Rush University Medical Center

Investigating the Role of Gas Flow in Transnasal Pulmonary Aerosol Delivery Via Nasal Cannula: A Double-blinded, Randomized Controlled Trial

Aerosol delivery via nasal cannula has gained increasing popularity, due to its combined benefits from aerosolized medication and heated warm oxygen therapy. In our previous in vitro study, we investigated the effects of the ratio of nasal cannula gas flow to subject's peak inspiratory flow (GF: IF) on the aerosol lung deposition, and we found that aerosol deposition in lung increased as the GF: IF decreased with an optimal GF: IF between 0.1 to 0.5 producing a stable "lung" deposition in both quiet and distress breathing. Thus we aimed to further validate such an optimal GF: IF in patients with reversible airflow limitations by the delivery of bronchodilators. Adult COPD or asthma patients who met ATS/ERS criteria for bronchodilator response in pulmonary function lab will be recruited and consented. After a washout period (1-3 days), patients will receive an escalating doubling dosage (0.5, 1, 2, and 4mg) of albuterol in total volume of 2mL, delivered by mesh nebulizer via nasal cannula. Patients will be randomly assigned to inhale bronchodilator into 3 group using different flows: 50 L/min,GF: IF = 1.0, and GF: IF = 0.5.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction Both in vitro and in vivo radiolabeled studies on nebulization via high flow nasal cannula (HFNC) showed that aerosol lung deposition decreased with the increasing nasal cannula gas flow, which, however, was not observed in patients with distressed breathing. In our previous in vitro study, we investigated the effects of the ratio of nasal cannula gas flow to subject's peak inspiratory flow (GF: IF) on the aerosol lung deposition, and we found that aerosol deposition in lung increased as the GF: IF decreased with an optimal GF: IF between 0.1 to 0.5 producing a stable "lung" deposition in both quiet and distress breathing. Thus we aimed to further validate such an optimal GF: IF in patients with reversible airflow limitations by the delivery of bronchodilators.

Methods and analysis COPD and asthma patients with positive response to four actuations of albuterol via metered dose inhaler (MDI) and valved holding chamber (VHC) will be enrolled and consented in the study. After a washout period (1-3 days), patients will be randomly assigned to three groups with different nasal cannula gas flow: 50L/min, GF: IF = 1.0, and GF: IF = 0.5. In each treatment arm, patients will firstly receive saline, then followed by an escalating doubling dosages (0.5, 1, 2, and 4mg) of albuterol in a total volume of 2mL, delivered by mesh nebulizer (VMN, Aerogen, Ireland) via heated nasal cannula at 37℃. An interval of 30 min will be maintained between two doses of albuterol, and pulmonary spirometry will be measured at baseline and after each dose. Titration will be terminated when an additional FEV1 improvement was < 5%.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • People's Liberation Army General Hospital

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Adult patients with positive bronchodilator responses to four actuations of albuterol (Ventolin, GSK, UK) via MDI with VHC (OptiChamber Diamond, Philips, USA) will be eligible for enrollment. A positive bronchodilator response is defined in accordance with ATS/ERS guidelines as follows: an increase in FEV1 of ≥ 12% and absolute change ≥ 200 mL from baseline.

Exclusion Criteria:

  • age ≥ 90 years old;
  • pregnancy;
  • pulmonary exacerbation within two weeks before enrollment;
  • reluctant to participate;
  • inability to complete the follow-up spirometry after each bronchodilator inhalation;
  • resting heart rate > 100bpm;
  • resting systolic blood pressure > 160mmHg or diastolic blood pressure > 110mmHg.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Gas flow 50 L/min
In this group, nasal cannula gas flow will be set at 50 L/min.
Other: nasal cannula gas flow
High flow nasal cannula (HFNC) is a relatively new oxygen device, which provides warmed and humidified oxygen for patients. When patients need to inhale aerosolized medication during HFNC, the nebulizer will be placed in-line in order to provide both treatments. This study will investigate the influence of three flow settings (50 L/min, GF:IF=1, GF:IF=0.5) on the clinical effects of nebulization.
EXPERIMENTAL: GF:IF=1
In this group, nasal cannula gas flow will be set at each individual patient's own inspiratory flow (GF:IF=1)
Other: nasal cannula gas flow
High flow nasal cannula (HFNC) is a relatively new oxygen device, which provides warmed and humidified oxygen for patients. When patients need to inhale aerosolized medication during HFNC, the nebulizer will be placed in-line in order to provide both treatments. This study will investigate the influence of three flow settings (50 L/min, GF:IF=1, GF:IF=0.5) on the clinical effects of nebulization.
EXPERIMENTAL: GF:IF=0.5
In this group, nasal cannula gas flow will be set at 50% of each individual patient's own inspiratory flow (GF:IF=0.5)
Other: nasal cannula gas flow
High flow nasal cannula (HFNC) is a relatively new oxygen device, which provides warmed and humidified oxygen for patients. When patients need to inhale aerosolized medication during HFNC, the nebulizer will be placed in-line in order to provide both treatments. This study will investigate the influence of three flow settings (50 L/min, GF:IF=1, GF:IF=0.5) on the clinical effects of nebulization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients who meet the positive criteria of responding to albuterol at the dose of 0.5mg
Time Frame: 30 minutes
The number of patients in HFNC nebulization who respond to albuterol at the dose of 0.5mg
30 minutes
The number of patients who meet the positive criteria of responding to albuterol at the dose of 1.5 mg
Time Frame: 60 minutes
The number of patients in HFNC nebulization who respond to albuterol at the dose of 1.5mg
60 minutes
The number of patients who meet the positive criteria of responding to albuterol at the dose of 3.5 mg
Time Frame: 90 minutes
The number of patients in HFNC nebulization who respond to albuterol at the dose of 3.5mg
90 minutes
The number of patients who meet the positive criteria of responding to albuterol at the dose of 7.5mg
Time Frame: 120 minutes
The number of patients in HFNC nebulization who respond to albuterol at the dose of 7.5mg
120 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the accumulative dose of albuterol required across groups to produce positive bronchodilation effects
Time Frame: 120 minutes
the accumulative dose of albuterol required to produce positive bronchodilation effects in each group
120 minutes
the incidence of side effect (tachycardia) in each group
Time Frame: 120 minutes
the incidence of side effect (tachycardia) will be recorded in each group
120 minutes
the incidence of side effect (tremor) in each group
Time Frame: 120 minutes
the incidence of side effect (tachycardia) will be recorded in each group
120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Collaborators

People's Liberation Army General Hospital

Investigators

  • Study Chair: Lixing Xie, MD, People's Liberation Army General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (ACTUAL)

February 1, 2019

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

November 9, 2018

First Posted (ACTUAL)

November 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HFNC-PFT-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data after deidentification that underlie the reports reported in this article can be obtained by contacting the corresponding author. Data will be available immediately following publication and ending in 5 years.

IPD Sharing Time Frame

5 years following publication

IPD Sharing Access Criteria

contacting the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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