The Effects of Different Flow Settings on Lung Impedance

NCT06228703 | Completed Results FDA Device

• 1 other identifier: HFNC-05
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

high-flow nasal cannula; ventilation distribution; lung impedance

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 4 hours

Secondary Outcomes (2)

• Changes in Respiratory Rates Compared to Baseline

  Up to 4 hours

• Subject's Comfort Level

  Up to 4 hours

Study Arms (6)

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

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

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

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

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

Interventions

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

Eligible participants will use the high-flow nasal cannula device (Airvo3 or HFT 750) with flow set at 40 L/min or higher

Also known as: HFNC flow at 40 L/min or higher

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

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers between 21-65 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University

Forest Park, Illinois, 60612, United States

Location

Related Publications (3)

• 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.

  PMID: 28940962 BACKGROUND

• Rochwerg 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.

  PMID: 30888444 BACKGROUND

• Li 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.

  PMID: 36855198 BACKGROUND

Limitations and Caveats

This study was conducted in healthy adult volunteers in a controlled laboratory environment, which may limit generalizability to clinical populations. The short intervention duration and immediate outcome assessments do not allow evaluation of longer-term effects.

Results Point of Contact

• Title: Jie Li
• Organization: Rush University

Jie_Li@rush.edu

3125634643

Study Officials

• JIE LI, PhD

  Rush University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: May 19, 2024
• Primary Completion: October 15, 2024
• Study Completion: October 26, 2024
• Last Updated: December 19, 2025
• Results First Posted: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)