Evaluation of Breathing Effort in Spontaneously Breathing Subjects
NCT ID: NCT04051645
Last Updated: 2021-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2019-06-24
2021-09-01
Brief Summary
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The main hypothesis tested is the differential effect of flow resistance on iWoB and iPTP parameters in spontaneous breathing of healthy probands.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Breathing through a system with adjustable flow resistance
During the experiment, the volunteers will breathe through ten adjustable flow resistances and their work of breathing will be measured.
Breathing 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.
Interventions
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Breathing 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.
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent has been obtained
Exclusion Criteria
* Pregnancy
* Cardiovascular disease
* Diabetes mellitus
18 Years
40 Years
ALL
Yes
Sponsors
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Czech Technical University in Prague
OTHER
Responsible Party
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Principal Investigators
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Karel Roubik, Prof.
Role: STUDY_DIRECTOR
Czech Technical University in Prague, Fac. of Biomedical Engineering
Locations
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Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University in Prague
Kladno, Czech Republic, Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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Bellani G, Pesenti A. Assessing effort and work of breathing. Curr Opin Crit Care. 2014 Jun;20(3):352-8. doi: 10.1097/MCC.0000000000000089.
de Vries H, Jonkman A, Shi ZH, Spoelstra-de Man A, Heunks L. Assessing breathing effort in mechanical ventilation: physiology and clinical implications. Ann Transl Med. 2018 Oct;6(19):387. doi: 10.21037/atm.2018.05.53.
Dodd DS, Kelly S, Collett PW, Engel LA. Pressure-time product, work rate, and endurance during resistive breathing in humans. J Appl Physiol (1985). 1988 Apr;64(4):1397-404. doi: 10.1152/jappl.1988.64.4.1397.
Collett PW, Perry C, Engel LA. Pressure-time product, flow, and oxygen cost of resistive breathing in humans. J Appl Physiol (1985). 1985 Apr;58(4):1263-72. doi: 10.1152/jappl.1985.58.4.1263.
Cabello B, Mancebo J. Work of breathing. Intensive Care Med. 2006 Sep;32(9):1311-4. doi: 10.1007/s00134-006-0278-3. Epub 2006 Jul 13. No abstract available.
Other Identifiers
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iWoBvsiPTP
Identifier Type: -
Identifier Source: org_study_id
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