Evaluation of Breathing Effort in Spontaneously Breathing Subjects

Healthy Clinical Trial

Official title:

Problems of Measurement and Evaluation of Breathing Effort in Spontaneously Breathing Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04051645
• Other study ID #: iWoBvsiPTP
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: February 2021
• Source: Czech Technical University in Prague
• Contact: Karel Roubík, Prof.
• Phone: +420603479901
• Email: roubik[@]fbmi.cvut.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Respiratory Aspiration

Intervention

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.

Locations

Country	Name	City	State
Czechia	Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University in Prague	Kladno	Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
Czech Technical University in Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (5)

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. — View Citation

Cabello B, Mancebo J. Work of breathing. Intensive Care Med. 2006 Sep;32(9):1311-4. Epub 2006 Jul 13. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iWoB	imposed work of breathing in J/s/L	through study completion, an average of 1 year
Primary	iPTP	imposed pressure time product in Pa.s/L	through study completion, an average of 1 year