High Flow Oxygen Therapy Effect on Healthy Subjects

• Sponsor: Argentinian Intensive Care Society (Other)
• Overall Status: Completed
• CT.gov ID: NCT06086769
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Actual Duration (Months): 4
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers; Diaphragm; Respiratory Rate	Device: High flow nasal canula	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Impact of High Flow Oxygen Therapy on Diaphragm Thickening Fraction in Healthy Subjects. A Prospective Cohort Study
• Actual Study Start Date: Mar 1, 2022
• Actual Primary Completion Date: May 30, 2022
• Actual Study Completion Date: Jun 30, 2022

Outcome Measures

Primary Outcome Measures

1. Diaphragm thickening fraction. [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 Outcome Measures

1. Respiratory Rate [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). [5 minutes each condition]

   Difference between basal Pes and maximum inspiratory Pes deflection.

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy subjects over 18 years old

Exclusion Criteria:

• contraindication for esophageal balloon placement

• diagnosis of lung disease

• smokers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Britanico de Buenos Aires	Ciudad Autónoma de Buenos Aires	Buenos Aires	Argentina	1280AED

Sponsors and Collaborators

• Argentinian Intensive Care Society

Investigators

• Study Chair: Gustavo A Plotnikow, RT, Hospital Británico de Buenos Aires

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gustavo Plotnikow, Principal investigator, Argentinian Intensive Care Society
• ClinicalTrials.gov Identifier: NCT06086769
• Other Study ID Numbers: CRIHB #1220 PRISA No. 6256
• First Posted: Oct 17, 2023
• Last Update Posted: Oct 17, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gustavo Plotnikow, Principal investigator, Argentinian Intensive Care Society: High flow nasal canula; High flow nasal canula therapy; Diaphragm thickening fraction; Work of breathing; Respiratory rate

Study Results

No Results Posted as of Oct 17, 2023