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Evaluation of Breathing Effort in Spontaneously Breathing Subjects

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04051645
Enrollment
20
Registered
2019-08-09
Start date
2019-06-24
Completion date
2021-09-01
Last updated
2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Work of breathing, Pressure Time Product, imposed WoB, imposed PTP, flow resistance

Brief summary

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

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.

Interventions

DEVICEBreathing through a system with adjustable flow resistance

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.

Sponsors

Czech Technical University in Prague
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

No masking will be done

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
iWoBthrough study completion, an average of 1 yearimposed work of breathing in J/s/L
iPTPthrough study completion, an average of 1 yearimposed pressure time product in Pa.s/L

Countries

Czechia

Contacts

Primary ContactKarel Roubík, Prof.
roubik@fbmi.cvut.cz+420603479901
Backup ContactJakub Rafl, PhD
rafl@fbmi.cvut.cz+420728229991

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026