Healthy Volunteers Clinical Trial
Official title:
Impact of High Flow Oxygen Therapy on Diaphragm Thickening Fraction in Healthy Subjects. A Prospective Cohort Study
Verified date | October 2023 |
Source | Argentinian Intensive Care Society |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | June 30, 2022 |
Est. primary completion date | May 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - healthy subjects over 18 years old Exclusion Criteria: - contraindication for esophageal balloon placement - diagnosis of lung disease - smokers |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Britanico de Buenos Aires | Ciudad Autónoma de Buenos Aires | Buenos Aires |
Lead Sponsor | Collaborator |
---|---|
Argentinian Intensive Care Society |
Argentina,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diaphragm thickening fraction. | 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 |
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) | |
Secondary | Respiratory Rate | The number of breaths per minute was recorded in 60 seconds. | The number of breaths per minute was recorded in 60 seconds. | |
Secondary | Esophageal pressure swing (Pes). | Difference between basal Pes and maximum inspiratory Pes deflection. | 5 minutes each condition | |
Secondary | Esophageal pressure-time product per minute (PTPes/min). | 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. | Through study completion, an average of 24 weeks |
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