The Effects of Different Flow Settings on Lung Impedance

NCT ID: NCT06228703

Last Updated: 2025-12-19

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-19

Study Completion Date

2024-10-26

Brief Summary

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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

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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

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Healthy

Keywords

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high-flow nasal cannula ventilation distribution lung impedance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Airvo 3 high-flow nasal cannula device with flow set at 20 L/min

A new high-flow nasal cannula device (Airvo 3) will be used in the study, with the flow set at 20 L/min

Group Type NO_INTERVENTION

No interventions assigned to this group

HFT 750 high-flow nasal cannula device with flow set at 20 L/min

A new high-flow nasal cannula device (HFT 750) will be used in the study, with the flow set at 20 L/min

Group Type NO_INTERVENTION

No interventions assigned to this group

Airvo 3 high-flow nasal cannula device with flow set at 40 L/min

Airvo 3 will be used with the flow set at 40 L/min

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Airvo 3 high-flow nasal cannula device with flow set at 60 L/min

Airvo 3 will be used with the flow set at 60 L/min

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

HFT 750 high-flow nasal cannula device with flow set at 40 L/min

HFT 750 will be used with the flow set at 40 L/min

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

HFT 750 high-flow nasal cannula device with flow set at 60 L/min

HFT 750 will be used with the flow set at 60 L/min

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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High-flow nasal cannula device with flow setting 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

Intervention Type DEVICE

Other Intervention Names

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HFNC flow at 40 L/min or higher

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JIE LI, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University

Locations

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Rush University

Forest Park, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28940962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30888444 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36855198 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HFNC-05

Identifier Type: -

Identifier Source: org_study_id