High Flow Oxygen Therapy Effect on Healthy Subjects

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06086769
• Other study ID #: CRIHB #1220 PRISA No. 6256
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2023
• Source: Argentinian Intensive Care Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diaphragm
• Healthy Volunteers
• Respiratory Rate

Intervention

Device:
• High 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

Locations

Country	Name	City	State
Argentina	Hospital Britanico de Buenos Aires	Ciudad Autónoma de Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Argentinian Intensive Care Society

Country where clinical trial is conducted

Argentina, 

Outcome

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