MedPath

The Effects of Different Flow Settings on Lung Impedance

Not Applicable
Completed
Conditions
Healthy
Interventions
Device: High-flow nasal cannula device with flow setting at 40 L/min or higher
Registration Number
NCT06228703
Lead Sponsor
Rush University Medical Center
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
26
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Airvo 3 high-flow nasal cannula device with flow set at 60 L/minHigh-flow nasal cannula device with flow setting at 40 L/min or higherAirvo 3 will be used with the flow set at 60 L/min
Airvo 3 high-flow nasal cannula device with flow set at 40 L/minHigh-flow nasal cannula device with flow setting at 40 L/min or higherAirvo 3 will be used with the flow set at 40 L/min
HFT 750 high-flow nasal cannula device with flow set at 40 L/minHigh-flow nasal cannula device with flow setting at 40 L/min or higherHFT 750 will be used with the flow set at 40 L/min
HFT 750 high-flow nasal cannula device with flow set at 60 L/minHigh-flow nasal cannula device with flow setting at 40 L/min or higherHFT 750 will be used with the flow set at 60 L/min
Primary Outcome Measures
NameTimeMethod
Lung aeration assessed by Electrical impedance tomographyUp to 4 hours

The distribution of air in different lung regions

Secondary Outcome Measures
NameTimeMethod
respiratory rateUp to 4 hours

respiratory rates are counted by the investigator for a minute and will be reported as breaths per minute

subject's comfort levelUp 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

Trial Locations

Locations (1)

Rush University

🇺🇸

Forest Park, Illinois, United States

© Copyright 2025. All Rights Reserved by MedPath