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Completed

NCT Number: NCT06086769

High Flow Oxygen Therapy Effect on Healthy Subjects

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.

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Key information

Conditions

Healthy Volunteers Diaphragm Respiratory Rate

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Britanico de Buenos Aires

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280AED, Argentina

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy subjects over 18 years old

Exclusion criteria

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

Treatment and study plan

high flow nasal canula

Device

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

Other names: diaphragm thickening fraction, esophageal pressure swing, Respiratory rate

Primary outcomes

  1. Diaphragm thickening fraction.

    Time frame: 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 outcomes

  1. Respiratory Rate

    Time frame: The number of breaths per minute was recorded in 60 seconds.

    The number of breaths per minute was recorded in 60 seconds.

  2. Esophageal pressure swing (Pes).

    Time frame: 5 minutes each condition

    Difference between basal Pes and maximum inspiratory Pes deflection.

  3. Esophageal pressure-time product per minute (PTPes/min).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Argentinian Intensive Care Society

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 17, 2023
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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