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The Effects of Different Flow Settings on Lung Impedance

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Status

Completed

Conditions

Healthy

Treatments

Device: High-flow nasal cannula device with flow setting at 40 L/min or higher

Study type

Interventional

Funder types

Other

Identifiers

NCT06228703
HFNC-05

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

26 participants in 6 patient groups

Airvo 3 high-flow nasal cannula device with flow set at 20 L/min
No Intervention group
Description:
A new high-flow nasal cannula device (Airvo 3) will be used in the study, with the flow set at 20 L/min
HFT 750 high-flow nasal cannula device with flow set at 20 L/min
No Intervention group
Description:
A new high-flow nasal cannula device (HFT 750) will be used in the study, with the flow set at 20 L/min
Airvo 3 high-flow nasal cannula device with flow set at 40 L/min
Experimental group
Description:
Airvo 3 will be used with the flow set at 40 L/min
Treatment:
Device: High-flow nasal cannula device with flow setting at 40 L/min or higher
Airvo 3 high-flow nasal cannula device with flow set at 60 L/min
Experimental group
Description:
Airvo 3 will be used with the flow set at 60 L/min
Treatment:
Device: High-flow nasal cannula device with flow setting at 40 L/min or higher
HFT 750 high-flow nasal cannula device with flow set at 40 L/min
Experimental group
Description:
HFT 750 will be used with the flow set at 40 L/min
Treatment:
Device: High-flow nasal cannula device with flow setting at 40 L/min or higher
HFT 750 high-flow nasal cannula device with flow set at 60 L/min
Experimental group
Description:
HFT 750 will be used with the flow set at 60 L/min
Treatment:
Device: High-flow nasal cannula device with flow setting at 40 L/min or higher

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Omar Alamoudi; Jie Li, PhD

Data sourced from clinicaltrials.gov

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