Evaluation of Breathing Effort in Spontaneously Breathing Subjects

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Device: Breathing through a system with adjustable flow resistance

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Czech Republic
    • Kladno, Czech Republic, Czechia, 27201
      • Recruiting
      • Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University in Prague
      • Contact: Karel Roubík, Prof.; Phone Number: +420 603 479 901; Email: roubik@fbmi.cvut.cz
      • Contact: Anna Miltová; Phone Number: +420 774 670 233; Email: anna.miltova@fbmi.cvut.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iWoB	imposed work of breathing in J/s/L	through study completion, an average of 1 year
iPTP	imposed pressure time product in Pa.s/L	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Czech Technical University in Prague
• Investigators: Study Director: Karel Roubik, Prof., Czech Technical University in Prague, Fac. of Biomedical Engineering

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Work of breathing; Pressure Time Product; imposed WoB; imposed PTP; flow resistance
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: iWoBvsiPTP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymous data from anesthesia monitor of vital functions

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No