The Effects of Different Flow Settings on Lung Impedance

December 3, 2025 updated by: Rush University Medical Center

The Effects of Different Flow Settings on Lung Impedance Using Two New HFNC Devices: A Randomized Crossover Study on Healthy Volunteers

This prospective, randomized crossover trial will enroll adult healthy volunteers. Initially, the subject's peak inspiratory flow will be measured using a mask connected with a respiratory monitor. Subsequently, the volunteers will undergo HFNC treatment at different flow settings while their peak inspiratory flow will be continuously monitored. The primary outcome of this study is the lung aeration with different flow settings. Secondary outcomes include the lung aeration with different devices, subject's comfort at different flow settings, and the correlation between the subject's peak inspiratory flow measured by HFNC and by a mask connected with a respiratory monitor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: High-flow nasal cannula (HFNC) is a device that can reduce the work of breathing (WOB) and improve oxygenation by providing a flow that matches or exceeds patient's peak inspiratory flow during tidal breathing. Despite its widespread use, there remains a lack of consensus regarding the optimal flow settings. Two new HFNC devices that can provide information regarding patient's peak tidal inspiratory flow breath by breath are recently available, which might help guide set and titrate the flow settings. This study aims to investigate the effects of different flow settings on lung impedance in a cohort of healthy volunteers by using the two new HFNC devices.

Methods: This prospective, randomized crossover trial will enroll adult healthy volunteers. Initially, the subject's peak inspiratory flow will be measured using a mask connected with a respiratory monitor. Subsequently, the volunteers will undergo HFNC treatment at different flow settings while their peak inspiratory flow will be continuously monitored. The primary outcome of this study is the lung aeration with different flow settings. Secondary outcomes include the lung aeration with different devices, subject's comfort at different flow settings, and the correlation between the subject's peak inspiratory flow measured by HFNC and by a mask connected with a respiratory monitor.

Study Type

Interventional

Enrollment (Actual)

26

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

  • United States
    • Illinois
      • Forest Park, Illinois, United States, 60612
        • Rush University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy volunteers between 21-65 years old

Exclusion Criteria:

  • Chronic pulmonary diseases, including COPD, interstitial lung disease, cystic fibrosis, etc.
  • Uncontrolled asthma;
  • Pregnancy
  • Subjects who have cold/flu symptoms (sore throat, runny nose, fever, chills, coughing)
  • Nose abnormalities that can affect the functionality of the nasal prongs

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Airvo 3 high-flow nasal cannula device with flow set at 20 L/min
A new high-flow nasal cannula device (Airvo 3) will be used in the study, with the flow set at 20 L/min
No Intervention: HFT 750 high-flow nasal cannula device with flow set at 20 L/min
A new high-flow nasal cannula device (HFT 750) will be used in the study, with the flow set at 20 L/min
Experimental: Airvo 3 high-flow nasal cannula device with flow set at 40 L/min
Airvo 3 will be used with the flow set at 40 L/min
Device: High-flow nasal cannula device with flow setting at 40 L/min or higher
Eligible participants will use the high-flow nasal cannula device (Airvo3 or HFT 750) with flow set at 40 L/min or higher
Other Names:
  • HFNC flow at 40 L/min or higher
Experimental: Airvo 3 high-flow nasal cannula device with flow set at 60 L/min
Airvo 3 will be used with the flow set at 60 L/min
Device: High-flow nasal cannula device with flow setting at 40 L/min or higher
Eligible participants will use the high-flow nasal cannula device (Airvo3 or HFT 750) with flow set at 40 L/min or higher
Other Names:
  • HFNC flow at 40 L/min or higher
Experimental: HFT 750 high-flow nasal cannula device with flow set at 40 L/min
HFT 750 will be used with the flow set at 40 L/min
Device: High-flow nasal cannula device with flow setting at 40 L/min or higher
Eligible participants will use the high-flow nasal cannula device (Airvo3 or HFT 750) with flow set at 40 L/min or higher
Other Names:
  • HFNC flow at 40 L/min or higher
Experimental: HFT 750 high-flow nasal cannula device with flow set at 60 L/min
HFT 750 will be used with the flow set at 60 L/min
Device: High-flow nasal cannula device with flow setting at 40 L/min or higher
Eligible participants will use the high-flow nasal cannula device (Airvo3 or HFT 750) with flow set at 40 L/min or higher
Other Names:
  • HFNC flow at 40 L/min or higher

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in End-expiratory Lung Impedance From Baseline Measured by Electrical Impedance Tomography (EIT)
Time Frame: Up to 4 hours
End-expiratory lung impedance (EELI) was measured continuously using electrical impedance tomography (EIT). For each flow-setting condition, EELI values were averaged over a stable 1-minute period. The outcome represents the change in EELI (in arbitrary impedance units) from each participant's baseline measurement prior to intervention. Positive values indicate an increase in end-expiratory lung volume compared to baseline, while negative values indicate a decrease. EIT impedance units are dimensionless and device-specific and are used to represent relative changes in ventilation and lung volume.
Up to 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Respiratory Rates Compared to Baseline
Time Frame: Up to 4 hours
Respiratory rate was measured as breaths per minute. Change was calculated as the value during each HFNC flow condition minus the baseline respiratory rate. Positive values indicate an increase in respiratory rate, and negative values indicate a decrease.
Up to 4 hours
Subject's Comfort Level
Time Frame: Up to 4 hours
Comfort level reported by participants using a visual numerical scale ranging between 0 (extreme discomfort) and 10 (very comfortable) at the end of each flow setting
Up to 4 hours

Collaborators and Investigators

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

Sponsor

Rush University Medical Center

Investigators

  • Principal Investigator: JIE LI, PhD, Rush University

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)

May 19, 2024

Primary Completion (Actual)

October 15, 2024

Study Completion (Actual)

October 26, 2024

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

January 18, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HFNC-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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