Evaluation of Breathing Effort in Spontaneously Breathing Subjects

NCT04051645 | Unknown

• 1 other identifier: iWoBvsiPTP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Work of breathing; Pressure Time Product; imposed WoB; imposed PTP; flow resistance

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Device: Breathing through a system with adjustable flow resistance

Interventions

Breathing through a system with adjustable flow resistance DEVICE

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.

Breathing through a system with adjustable flow resistance

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females \> 18 and \< 40 years old
• Signed informed consent has been obtained

You may not qualify if:

• Respiratory disease
• Pregnancy
• Cardiovascular disease
• Diabetes mellitus

Sponsors & Collaborators

• Czech Technical University in Prague: lead

Study Sites (1)

Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University in Prague

Kladno, Czech Republic, 27201, Czechia

RECRUITING

Related 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.

  PMID: 24722059 BACKGROUND

• 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.

  PMID: 30460261 BACKGROUND

• 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.

  PMID: 3378975 BACKGROUND

• 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.

  PMID: 3988680 BACKGROUND

• 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.

  PMID: 16838150 BACKGROUND

Study Officials

• Karel Roubik, Prof.

  Czech Technical University in Prague, Fac. of Biomedical Engineering

  STUDY DIRECTOR

Central Study Contacts

Karel Roubík, Prof.

CONTACT

+420603479901; roubik@fbmi.cvut.cz

Jakub Rafl, PhD

CONTACT

+420728229991; rafl@fbmi.cvut.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking will be done
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 9, 2019
• Study Start: June 24, 2019
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)