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CompletedNCT06086769Updated Oct 17, 2023

High Flow Oxygen Therapy Effect on Healthy Subjects

An interventional study of High flow nasal canula in Healthy Volunteers, Diaphragm and Respiratory Rate, sponsored by Argentinian Intensive Care Society. Completed at 1 site in Argentina. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-17.

Sponsored by Argentinian Intensive Care Society · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Mar 2022, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Non-randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers
  • Diaphragm
  • Respiratory Rate

Keywords

  • High flow nasal canula
  • High flow nasal canula therapy
  • Diaphragm thickening fraction
  • Work of breathing
  • Respiratory rate
03

In context

Lead sponsor

Argentinian Intensive Care Society is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy subjects over 18 years old

Exclusion criteria

Exclusion Criteria:

  • contraindication for esophageal balloon placement
  • diagnosis of lung disease
  • smokers
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
13 participants (actual)

Interventions

  • DeviceHigh flow nasal canula

    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

    Also known as: diaphragm thickening fraction, esophageal pressure swing, Respiratory rate

06

What researchers measure

Primary outcomes

  1. 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

    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)

Secondary outcomes

  1. Respiratory Rate

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

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

  2. Esophageal pressure swing (Pes).

    Difference between basal Pes and maximum inspiratory Pes deflection.

    Time frame: 5 minutes each condition

  3. 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.

    Time frame: Through study completion, an average of 24 weeks

07

Study locations

1 site
  • Hospital Britanico de Buenos Aires
    Ciudad Autónoma de Buenos Aires, Buenos Aires 1280AED, Argentina
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06086769
Lead sponsor
Argentinian Intensive Care Society
Responsible party
Gustavo Plotnikow (Principal investigator, Argentinian Intensive Care Society) — Principal investigator
First posted
Oct 17, 2023
Start date
Mar 1, 2022
Primary completion
May 30, 2022
Completion
Jun 30, 2022
Last update
Oct 17, 2023

Study contacts

Gustavo A Plotnikow, RT
study chair · Hospital Británico de Buenos Aires

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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