Evaluation of Breathing Effort in Spontaneously Breathing Subjects

Not Applicable

• Conditions: Healthy
• Interventions: Device: Breathing through a system with adjustable flow resistance

• Registration Number: NCT04051645
• Lead Sponsor: Czech Technical University in Prague

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.

Study Timeline

• Study Start: 2019-06-24
• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-26
• Primary Completion: 2021-06-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breathing through a system with adjustable flow resistance	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University in Prague; 🇨🇿 Kladno, Czech Republic, Czechia