The Effects of Different Flow Settings on Lung Impedance

Healthy Clinical Trial

Official title:

The Effects of Different Flow Settings on Lung Impedance Using Two New HFNC Devices: A Randomized Crossover Study on Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06228703
• Other study ID #: HFNC-05
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Rush University Medical Center
• Contact: Omar Alamoudi
• Phone: 312-563-4643
• Email: Omar_A_Alamoudi[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: December 31, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Rush University	Forest Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung aeration assessed by Electrical impedance tomography	The distribution of air in different lung regions	Up to 4 hours
Secondary	respiratory rate	respiratory rates are counted by the investigator for a minute and will be reported as breaths per minute	Up to 4 hours
Secondary	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	Up to 4 hours