Clinical trial NCT04051645: Evaluation of Breathing Effort in Spontaneously Breathing Subjects
Official title: Problems of Measurement and Evaluation of Breathing Effort in Spontaneously Breathing Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Work of breathing
Pressure Time Product
imposed WoB
imposed PTP
flow resistance
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: iWoB
timeFrame: through study completion, an average of 1 year
measure: iPTP
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University in Prague
state: Czech Republic
Study officials:
affiliation: Czech Technical University in Prague, Fac. of Biomedical Engineering
name: Karel Roubik, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.