The Effects of Different Flow Settings on Lung Impedance

Not Applicable

Completed

• Conditions: Healthy

• 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.

Study Timeline

• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-29
• Study Start: 2024-05-19
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19

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

Primary Outcome Measures

Name	Time	Method
Lung aeration assessed by Electrical impedance tomography	Up to 4 hours	The distribution of air in different lung regions

Secondary Outcome Measures

Name	Time	Method
respiratory rate	Up to 4 hours	respiratory rates are counted by the investigator for a minute and will be reported as breaths per minute
subject's comfort level	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

Trial Locations

Locations (1)

Rush University; 🇺🇸 Forest Park, Illinois, United States