High Flow Oxygen Therapy Effect on Healthy Subjects

NCT06086769 | Completed DMC

• 1 other identifier: CRIHB #1220 PRISA No. 6256
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers; Diaphragm; Respiratory Rate

Keywords

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

Outcome Measures

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

  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 (3)

• Respiratory Rate

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

• Esophageal pressure swing (Pes).

  5 minutes each condition

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

  Through study completion, an average of 24 weeks

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy subjects over 18 years old

You may not qualify if:

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

Sponsors & Collaborators

• Argentinian Intensive Care Society: lead

Study Sites (1)

Hospital Britanico de Buenos Aires

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

Location

MeSH Terms

Interventions

Respiratory Rate

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Gustavo A Plotnikow, RT

  Hospital Británico de Buenos Aires

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 17, 2023
• Study Start: March 1, 2022
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

AR (1)