High Flow Oxygen Therapy Effect on Healthy Subjects

Not Applicable

Completed

• Conditions: Diaphragm; Healthy Volunteers; Respiratory Rate

• Registration Number: NCT06086769
• Lead Sponsor: Argentinian Intensive Care Society

Brief Summary

The use of high-flow nasal cannula (HFNC) has increased. Diaphragmatic ultrasonography is a tool that, as a noninvasive complement to esophageal pressure (Pes) measurement, allows the evaluation of diaphragm function and reflects, through the diaphragm thickening fraction (DTf), the magnitude of diaphragmatic fiber recruitment. The objective of this study was to evaluate the impact of HFNC therapy on the DTf in healthy subjects. Second, this study aimed to assess the behavior of the respiratory rate (RR) and the work of breathing in these subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-05-30
• Study Completion: 2022-06-30
• Study First Submitted: 2023-09-29
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-11
• Last Update Submitted: 2023-10-11
• Study First Posted: 2023-10-17
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• healthy subjects over 18 years old

Exclusion Criteria

• contraindication for esophageal balloon placement
• diagnosis of lung disease
• smokers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Diaphragm thickening fraction.	Immediately after 5 min of each condition (baseline, 20 and 40 liters per minute) the diaphragmatic thickness was measured at the end of inspiration y de la expiration during 3 consecutive respiratory cycles (each cycle is between 3 and 10 seconds)	ultrasound measurements were performed by an expert operator (the same in all cases). The ultrasound measurement was performed using a high-resolution linear transducer in real-time in B-mode.; The diaphragm thickness was measured at the end of expiration and the end of inspiration of the same ventilatory cycle and the average value of 3 ventilatory cycles was recorded. A 2-minute washout period was allowed between each test condition to avoid the summation of effects.; The DTf and PTPes/min were calculated for each subject in each available condition (baseline - without flow- , wtih 20 and 40 liters per minute): DTf = End Inspiratory Diaphragm thickening - End Expiratory Diaphragm thickening / End Expiratory Diaphragm thickening x 100

Secondary Outcome Measures

Name	Time	Method
Esophageal pressure swing (Pes).	5 minutes each condition	Difference between basal Pes and maximum inspiratory Pes deflection.
Esophageal pressure-time product per minute (PTPes/min).	Through study completion, an average of 24 weeks	It was calculated as the area determined by esophageal deflection multiplied by respiratory rate. An ad hoc software developed in MATLAB R2018b (The MathWorks, Inc. Massachusetts, United States) was used for this purpose.
Respiratory Rate	The number of breaths per minute was recorded in 60 seconds.	The number of breaths per minute was recorded in 60 seconds.

Trial Locations

Locations (1)

Hospital Britanico de Buenos Aires; 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina