Evaluation of Breathing Effort in Spontaneously Breathing Subjects

Study Overview
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Brief Summary
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The aim of the research project is to evaluate the breathing effort using the Work of Breathing (WoB) and Pressure-Time Product (PTP) parameters, depending on the increasing flow resistance. The research project is concerned with assessing the increased (imposed) breathing effort using the Work of Breathing (iWoB) and the Pressure-Time Product (iPTP). The main hypothesis tested is the differential effect of flow resistance on iWoB and iPTP parameters in spontaneous breathing of healthy probands.

Detailed Description
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Due to the different calculation of iWoB and iWoB, these parameters may be affected at higher flow resistance values. The proposed experiment will be used to compare iWoB and iPTP obtained during spontaneous breathing to healthy subjects.

Official Title
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Problems of Measurement and Evaluation of Breathing Effort in Spontaneously Breathing Subjects

Conditions
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Healthy

Intervention / Treatment
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* Device: Breathing through a system with adjustable flow resistance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females > 18 and < 40 years old Signed informed consent has been obtained Exclusion Criteria: Respiratory disease Pregnancy Cardiovascular disease Diabetes mellitus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: In the experiment, the proband will breathe through the D-Lite measuring screen of the Datex-Ohmeda S/5 Patient Monitor patient monitor (GE, USA). Unlike clinical practice, an adjustable flow resistance will be connected to the system. The flow resistance is set by adjustable by a removable diaphragm with different hole diameters according to the intended flow resistance.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breathing through a system with adjustable flow resistance<br>During the experiment, the volunteers will breathe through ten adjustable flow resistances and their work of breathing will be measured. | Device: Breathing through a system with adjustable flow resistance<br>* The proband will breathe through the adjustable flow resistance within the experiment, to which a standard D-lite Flow sensor will be connected, and the airway pressure, flow, minute consumption, oxygen and carbon dioxide, tidal volume, oxygen saturation of peripheral blood and oxygen and carbon dioxide concentrations in both inspired and expired air will be recorded using the Datex-Ohmeda S/5 Patient Monitor vital signs monitor. The proband will breathe through the flow resistors in a randomized order, and pre-defined three-minute pauses will be maintained between measurements with different flow resistance values. Each measurement will take approximately two minutes and will be measured on ten different flow resistances.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iWoB | imposed work of breathing in J/s/L | through study completion, an average of 1 year | 
| iPTP | imposed pressure time product in Pa.s/L | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Work of breathing, Pressure Time Product, imposed WoB, imposed PTP, flow resistance