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High Flow Oxygen Therapy Effect on Healthy Subjects

Impact of High Flow Oxygen Therapy on Diaphragm Thickening Fraction in Healthy Subjects. A Prospective Cohort Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06086769
Enrollment
13
Registered
2023-10-17
Start date
2022-03-01
Completion date
2022-06-30
Last updated
2023-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragm, Healthy Volunteers, Respiratory Rate

Keywords

High flow nasal canula, High flow nasal canula therapy, Diaphragm thickening fraction, Work of breathing, Respiratory rate

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.

Interventions

Measurement of diaphragm thickening fraction, respiratory rate and esophageal pressure swing with calculation of diaphragmatic pressure-time product without the use of HFNC and with the use of HFNC at 20 and 40 Liters per minute

Sponsors

Argentinian Intensive Care Society
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy subjects over 18 years old

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Respiratory RateThe number of breaths per minute was recorded in 60 seconds.The number of breaths per minute was recorded in 60 seconds.
Esophageal pressure swing (Pes).5 minutes each conditionDifference between basal Pes and maximum inspiratory Pes deflection.
Esophageal pressure-time product per minute (PTPes/min).Through study completion, an average of 24 weeksIt 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.

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026