Evaluation of Breathing Effort in Spontaneously Breathing Subjects
Primary Purpose
Healthy
Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Breathing through a system with adjustable flow resistance
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring Work of breathing, Pressure Time Product, imposed WoB, imposed PTP, flow resistance
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
Sites / Locations
- Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University in PragueRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Breathing through a system with adjustable flow resistance
Arm Description
During the experiment, the volunteers will breathe through ten adjustable flow resistances and their work of breathing will be measured.
Outcomes
Primary Outcome Measures
iWoB
imposed work of breathing in J/s/L
iPTP
imposed pressure time product in Pa.s/L
Secondary Outcome Measures
Full Information
NCT ID
NCT04051645
First Posted
August 6, 2019
Last Updated
February 24, 2021
Sponsor
Czech Technical University in Prague
1. Study Identification
Unique Protocol Identification Number
NCT04051645
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Czech Technical University in Prague
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Work of breathing, Pressure Time Product, imposed WoB, imposed PTP, flow resistance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
No masking will be done
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Breathing through a system with adjustable flow resistance
Arm Type
Experimental
Arm Description
During the experiment, the volunteers will breathe through ten adjustable flow resistances and their work of breathing will be measured.
Intervention Type
Device
Intervention Name(s)
Breathing through a system with adjustable flow resistance
Intervention Description
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.
Primary Outcome Measure Information:
Title
iWoB
Description
imposed work of breathing in J/s/L
Time Frame
through study completion, an average of 1 year
Title
iPTP
Description
imposed pressure time product in Pa.s/L
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karel Roubík, Prof.
Phone
+420603479901
Email
roubik@fbmi.cvut.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Jakub Rafl, PhD
Phone
+420728229991
Email
rafl@fbmi.cvut.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel Roubik, Prof.
Organizational Affiliation
Czech Technical University in Prague, Fac. of Biomedical Engineering
Official's Role
Study Director
Facility Information:
Facility Name
Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University in Prague
City
Kladno
State/Province
Czech Republic
ZIP/Postal Code
27201
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karel Roubík, Prof.
Phone
+420 603 479 901
Email
roubik@fbmi.cvut.cz
First Name & Middle Initial & Last Name & Degree
Anna Miltová
Phone
+420 774 670 233
Email
anna.miltova@fbmi.cvut.cz
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Anonymous data from anesthesia monitor of vital functions
Citations:
PubMed Identifier
24722059
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.
Results Reference
background
PubMed Identifier
30460261
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.
Results Reference
background
PubMed Identifier
3378975
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.
Results Reference
background
PubMed Identifier
3988680
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.
Results Reference
background
PubMed Identifier
16838150
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.
Results Reference
background
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Evaluation of Breathing Effort in Spontaneously Breathing Subjects
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