HealthyNCT04051645
Evaluation of Breathing Effort in Spontaneously Breathing Subjects
A study testing Breathing through a system with adjustable flow resistance in people with Healthy, run by Czech Technical University in Prague at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Breathing through a system with adjustable flow resistance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 24 Jun 2019to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females > 18 and < 40 years old
- Signed informed consent has been obtained
Who cannot join
- Respiratory disease
- Pregnancy
- Cardiovascular disease
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University in Prague
Kladno, Czech Republic, 27201
Karel Roubík, Prof., +420 603 479 901, roubik@fbmi.cvut.cz
Anna Miltová, +420 774 670 233, anna.miltova@fbmi.cvut.cz
About this study
Official title: Problems of Measurement and Evaluation of Breathing Effort in Spontaneously Breathing Subjects
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Breathing through a system with adjustable flow resistance
- Keywords
- Work of breathing, Pressure Time Product, imposed WoB, imposed PTP, flow resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing through a system with adjustable flow resistanceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Breathing through a system with adjustable flow resistance | Experimental | During the experiment, the volunteers will breathe through ten adjustable flow resistances and their work of breathing will be measured. Receives: Device: Breathing through a system with adjustable flow resistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
iWoB
imposed work of breathing in J/s/L
Measured: through study completion, an average of 1 year
iPTP
imposed pressure time product in Pa.s/L
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start24 Jun 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karel Roubik, Prof., Study director, Czech Technical University in Prague, Fac. of Biomedical Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051645
- Sponsor's protocol ID
- iWoBvsiPTP
- Status last verified
- Feb 2021
- First submitted
- 6 Aug 2019
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymous data from anesthesia monitor of vital functions
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.
PubMed 24722059de 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.
PubMed 30460261Dodd 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.
PubMed 3378975Collett 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.
PubMed 3988680Cabello 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.
PubMed 16838150
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Problems of Measurement and Evaluation of Breathing Effort in Spontaneously Breathing Subjects
- ClinicalTrials.gov ID
- NCT04051645
- Acronym / sponsor ID
- iWoBvsiPTP
- Conditions
- Healthy
- Keywords
- Work of breathing, Pressure Time Product, imposed WoB, imposed PTP, flow resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Breathing through a system with adjustable flow resistance | Experimental | Device: Breathing through a system with adjustable flow resistanceDuring the experiment, the volunteers will breathe through ten adjustable flow resistances and their work of breathing will be measured. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males and females > 18 and < 40 years old
- Signed informed consent has been obtained
Key exclusion criteria (4 listed)
- Respiratory disease
- Pregnancy
- Cardiovascular disease
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing through a system with adjustable flow resistanceThe 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. | Device | Breathing through a system with adjustable flow resistance |
Primary outcome
iWoB
Time frame: through study completion, an average of 1 year
imposed work of breathing in J/s/L
iPTP
Time frame: through study completion, an average of 1 year
imposed pressure time product in Pa.s/L
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Background: PubMed 24722059Bellani G, Pesenti A. Assessing effort and work of breathing. Curr Opin Crit Care. 2014 Jun;20(3):352-8. doi: 10.1097/MCC.0000000000000089.
- Background: PubMed 30460261de 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.
- Background: PubMed 3378975Dodd 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.
- Background: PubMed 3988680Collett 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.
- Background: PubMed 16838150Cabello 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.
- Individual participant dataSharing planned: No. Anonymous data from anesthesia monitor of vital functions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karel Roubik, Prof. study director
Czech Technical University in Prague, Fac. of Biomedical Engineering
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing through a system with adjustable flow resistance in people with Healthy, run by Czech Technical University in Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karel Roubík, Prof. (+420603479901, roubik@fbmi.cvut.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iWoB (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04051645, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.