Clinical trial NCT06228703: The Effects of Different Flow Settings on Lung Impedance
Official title: The Effects of Different Flow Settings on Lung Impedance Using Two New HFNC Devices: A Randomized Crossover Study on Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: high-flow nasal cannula
ventilation distribution
lung impedance
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lung aeration assessed by Electrical impedance tomography
timeFrame: Up to 4 hours
Secondary outcomes:
measure: respiratory rate
timeFrame: Up to 4 hours
measure: subject's comfort level
timeFrame: Up to 4 hours
Other outcomes:
Locations:
city: Forest Park
country: United States
facility: Rush University
state: Illinois
Study officials:
affiliation: Rush University
name: JIE LI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.