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NCT05302219 Clinical Trial

Plethysmography Curve Variability Depending on the Breath Cycle

Apnea Clinical Trial

Official title:
Plethysmography Curve Variability Depending on the Breath Cycle

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05302219
Other study ID # Plethysmography2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 10, 2022
Est. completion date June 30, 2022

Study information
Verified date March 2022
Source Czech Technical University in Prague
Contact Veronika Rafl Huttova, MSc
Phone +420224355049
Email huttover@fbmi.cvut.cz
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to analyze the variability of plethysmography curve depending on the breath cycle (respiratory rate and tidal volume).

Description:

The plethysmography curve measured by finger sensors using pulse oximetry shows the changes in blood volume at the measured site. The presence of respiratory information within the pulse oximeter signal is a well-documented phenomenon. However, previous studies have mainly focused on extracting the respiratory rate from the plethysmography curve. The aim of this study is to analyze the variability of plethysmography curve as a function of both respiratory rate and tidal volume. Furthermore, the aim is to analyze the possibilities of apneic pause detection from the plethysmography curve.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - healthy volunteers/students from the Czech Technical University in Prague Exclusion Criteria: - any acute illness - pregnancy - severe cardiovascular conditions - severe asthma or other severe respiratory conditions - diabetes - hypotension or hypertension

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Respiratory rate
The participant alternates respiratory rates of 30, 15 and 7.5 breaths/min. Breathe each frequency for 2 minutes with a one-minute break.
• Tidal volume
The participant alternates tidal volumes of approx. 2, 1 and 0.5 litres. Breathe each tidal volume for 2 minutes with a one-minute break.
• Apnea
The participant simulates three apneic pauses lasting 1 minute with a two-minute break.

Locations
Country Name City State
Czechia Faculty of Biomedical Engineering, Czech Technical University in Prague Kladno

Sponsors (1)
Lead Sponsor Collaborator
Czech Technical University in Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

Nilsson LM. Respiration signals from photoplethysmography. Anesth Analg. 2013 Oct;117(4):859-865. doi: 10.1213/ANE.0b013e31828098b2. Epub 2013 Feb 28. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Variability of plethysmography curve depending on the respiratory rate The effect of different respiratory rates (including apnea-zero respiratory rate) on the shape of the plethysmography curve will be evaluated. 1 hour
Primary Variability of plethysmography curve depending on the tidal volume The effect of different tidal volumes (including apnea-zero tidal volume) on the shape of the plethysmography curve will be evaluated. 1 hour
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