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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06086769
Other study ID # CRIHB #1220 PRISA No. 6256
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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