HealthyNCT06228703
The Effects of Different Flow Settings on Lung Impedance
A study testing High-flow nasal cannula device with flow setting at 40 L/min or higher in people with Healthy, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High-flow nasal cannula device with flow setting at 40 L/min or higher
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2024to 26 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers between 21-65 years old
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- High-flow nasal cannula device with flow setting at 40 L/min or higher
- Keywords
- high-flow nasal cannula, ventilation distribution, lung impedance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal cannula device with flow setting at 40 L/min or higherDevice
Also called HFNC flow 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
| Study group | Role | What they receive |
|---|---|---|
| Airvo 3 high-flow nasal cannula device with flow set at 20 L/min | No intervention | 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 | 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 | Airvo 3 will be used with the flow set at 40 L/min Receives: 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 | Airvo 3 will be used with the flow set at 60 L/min Receives: 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 | HFT 750 will be used with the flow set at 40 L/min Receives: 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 | HFT 750 will be used with the flow set at 60 L/min Receives: Device: High-flow nasal cannula device with flow setting at 40 L/min or higher |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in End-expiratory Lung Impedance From Baseline Measured by Electrical Impedance Tomography (EIT)
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.
Measured: Up to 4 hours
Secondary outcomes (2)
Changes in Respiratory Rates Compared to Baseline
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.
Measured: Up to 4 hours
Subject's Comfort Level
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
Measured: Up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start19 May 2024
- Primary completion15 Oct 2024
- Study completion26 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JIE LI, PhD, Principal investigator, Rush University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228703
- Sponsor's protocol ID
- HFNC-05
- Status last verified
- Dec 2025
- First submitted
- 18 Jan 2024
- Last updated
- 19 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
McKinstry S, Pilcher J, Bardsley G, Berry J, Van de Hei S, Braithwaite I, Fingleton J, Weatherall M, Beasley R. Nasal high flow therapy and PtCO2 in stable COPD: A randomized controlled cross-over trial. Respirology. 2018 Apr;23(4):378-384. doi: 10.1111/resp.13185. Epub 2017 Sep 22.
PubMed 28940962Rochwerg B, Granton D, Wang DX, Helviz Y, Einav S, Frat JP, Mekontso-Dessap A, Schreiber A, Azoulay E, Mercat A, Demoule A, Lemiale V, Pesenti A, Riviello ED, Mauri T, Mancebo J, Brochard L, Burns K. High flow nasal cannula compared with conventional oxygen therapy for acute hypoxemic respiratory failure: a systematic review and meta-analysis. Intensive Care Med. 2019 May;45(5):563-572. doi: 10.1007/s00134-019-05590-5. Epub 2019 Mar 19.
PubMed 30888444Li J, Albuainain FA, Tan W, Scott JB, Roca O, Mauri T. The effects of flow settings during high-flow nasal cannula support for adult subjects: a systematic review. Crit Care. 2023 Feb 28;27(1):78. doi: 10.1186/s13054-023-04361-5.
PubMed 36855198
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Flow Settings on Lung Impedance Using Two New HFNC Devices: A Randomized Crossover Study on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06228703
- Acronym / sponsor ID
- HFNC-05
- Conditions
- Healthy
- Keywords
- high-flow nasal cannula, ventilation distribution, lung impedance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 19 May 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 26 Oct 2024 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Posted 19 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Airvo 3 high-flow nasal cannula device with flow set at 20 L/min | No intervention | –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 | –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 | Device: High-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 |
| Airvo 3 high-flow nasal cannula device with flow set at 60 L/min | Experimental | Device: High-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 |
| HFT 750 high-flow nasal cannula device with flow set at 40 L/min | Experimental | Device: High-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/min | Experimental | Device: High-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 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers between 21-65 years old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-flow nasal cannula device with flow setting at 40 L/min or higherAlso: HFNC flow at 40 L/min or higherEligible participants will use the high-flow nasal cannula device (Airvo3 or HFT 750) with flow set at 40 L/min or higher | Device | Airvo 3 high-flow nasal cannula device with flow set at 40 L/min, Airvo 3 high-flow nasal cannula device with flow set at 60 L/min, HFT 750 high-flow nasal cannula device with flow set at 40 L/min, HFT 750 high-flow nasal cannula device with flow set at 60 L/min |
Primary outcome
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.
2 secondary outcomes
Changes in Respiratory Rates Compared to Baseline
Time frame: Up to 4 hours
Subject's Comfort Level
Time frame: Up to 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28940962McKinstry S, Pilcher J, Bardsley G, Berry J, Van de Hei S, Braithwaite I, Fingleton J, Weatherall M, Beasley R. Nasal high flow therapy and PtCO2 in stable COPD: A randomized controlled cross-over trial. Respirology. 2018 Apr;23(4):378-384. doi: 10.1111/resp.13185. Epub 2017 Sep 22.
- Background: PubMed 30888444Rochwerg B, Granton D, Wang DX, Helviz Y, Einav S, Frat JP, Mekontso-Dessap A, Schreiber A, Azoulay E, Mercat A, Demoule A, Lemiale V, Pesenti A, Riviello ED, Mauri T, Mancebo J, Brochard L, Burns K. High flow nasal cannula compared with conventional oxygen therapy for acute hypoxemic respiratory failure: a systematic review and meta-analysis. Intensive Care Med. 2019 May;45(5):563-572. doi: 10.1007/s00134-019-05590-5. Epub 2019 Mar 19.
- Background: PubMed 36855198Li J, Albuainain FA, Tan W, Scott JB, Roca O, Mauri T. The effects of flow settings during high-flow nasal cannula support for adult subjects: a systematic review. Crit Care. 2023 Feb 28;27(1):78. doi: 10.1186/s13054-023-04361-5.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JIE LI, PhD principal investigator
Rush University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow nasal cannula device with flow setting at 40 L/min or higher in people with Healthy, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in End-expiratory Lung Impedance From Baseline Measured by Electrical Impedance Tomography (EIT) (time frame: Up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06228703, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.