Plethysmography Curve Variability Depending on the Breath Cycle

March 24, 2025 updated by: Czech Technical University in Prague
The aim of the study is to analyze the variability of plethysmography curve depending on the breath cycle (respiratory rate and tidal volume).

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kladno, Czechia, 27201
        • Faculty of biomedical Engineering, Czech Technical University in Prague

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Measurement of plethysmography curve
Calm measurement of plethysmography curve using pulse oximetry with simultaneous monitoring of the breath cycle. In this experimental arm, participants will vary their breath cycle (different respiratory rates and different tidal volumes).
The participant alternates respiratory rates of 30, 15 and 7.5 breaths/min. Breathe each frequency for 2 minutes with a one-minute break.
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.
The participant simulates three apneic pauses lasting 1 minute with a two-minute break.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Veronika Rafl Huttova, MSc, Czech Technical University in Prague
  • Principal Investigator: Jakub Rafl, PhD, Czech Technical University in Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Plethysmography2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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