Evaluation of Breathing Effort in Spontaneously Breathing Subjects
Sponsor
Czech Technical University in Prague (Other)
Overall Status
Recruiting
CT.gov ID
NCT04051645
Collaborator
(none)
20
1
1
26.3
0.8
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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)
Masking Description:
No masking will be done
Primary Purpose:
Basic Science
Official Title:
Problems of Measurement and Evaluation of Breathing Effort in Spontaneously Breathing Subjects
Actual Study Start Date
:
Jun 24, 2019
Anticipated Primary Completion Date
:
Jun 1, 2021
Anticipated Study Completion Date
:
Sep 1, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- iWoB [through study completion, an average of 1 year]
imposed work of breathing in J/s/L
- iPTP [through study completion, an average of 1 year]
imposed pressure time product in Pa.s/L
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 40 Years
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University in Prague | Kladno | Czech Republic | Czechia | 27201 |
Sponsors and Collaborators
- Czech Technical University in Prague
Investigators
- Study Director: Karel Roubik, Prof., Czech Technical University in Prague, Fac. of Biomedical Engineering
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- Cabello B, Mancebo J. Work of breathing. Intensive Care Med. 2006 Sep;32(9):1311-4. Epub 2006 Jul 13. Review.
- 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.
- 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. Review.
- 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.
Responsible Party:
Czech Technical University in Prague
ClinicalTrials.gov Identifier:
NCT04051645
Other Study ID Numbers:
- iWoBvsiPTP
First Posted:
Aug 9, 2019
Last Update Posted:
Feb 26, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Czech Technical University in Prague
Additional relevant MeSH terms: